[{"country_short": "USA", "city": "Irvine", "description": "Quality Engineer\nJob Requisition #: AF13886\nDate Posted: 05/21/2012\nCategory: Engineering Quality\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe are seeking a high caliber, hands-on experienced Quality Assurance Engineer. This position provides quality support to our EnSite product line and works closely with manufacturing. This Engineer will monitor quality on the production floor working with inspectors. This Engineer will work closely with production engineers during product development activities to ensure quality checkpoints are in place as part of the production process.\n\nImpact this role will have:\n\u2022 Performs process and product qualification as outlined in a validation protocol to ensure finished products meet standards.\n\u2022 Works closely with production engineers to ensure quality checkpoints are in place as part of the production process and that processes are clear and concise.\n\u2022 Assists in the implementation of changes required as a result of internal audit findings.\n\u2022 Assists with IQ/OQ during development stage in preparation for process implementation.\n\u2022 Participates on new product development cross-functional teams.\n\u2022 Performs material processing.\n\u2022 Performs statistical analysis reports on a monthly basis.\n\nRequired Qualifications:\n\u2022 Bachelor\u2019s degree in Electrical Engineering\n\u2022 3+ years of experience in a quality assurance role within a manufacturing environment\n\u2022 Experience with different types of testing including analytical testing, performance testing, design verification testing, material testing, and chemistry\n\u2022 Knowledge of standards\n\u2022 Experience with materials testing, analytical testing, performance testing, biocompatibility testing, design verification testing\n\u2022 Experience supporting a manufacturing environment\n\u2022 Polished communicator- written documentation and oral presentations/ discussions/ meetings\n\u2022 Excellent reputation for building relationships\n\u2022 Organized, on-time, and detailed project management skills\n\u2022 Energized attitude\n\nPreferred Qualifications:\n\u2022 Soldering certification\n\u2022 Medical device experience\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-21 20:25:06", "url": "http://jobs.sjm.com/xml/28837110/job", "country": "United States", "company": "St. Jude Medical", "title": "Quality Engineer", "reqid": "AF13886", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 28837110}, {"country_short": "USA", "city": "Minnetonka", "description": "Software Quality Engineer II\nJob Requisition #: 12878\nDate Posted: 05/01/2012\nCategory: Software Quality Control Engineering\nLocation: Minnetonka - MN - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka.\n\nJob Overview\nThe Software Quality Engineer II is responsible for executing and maintaining quality engineering methodologies and providing quality engineering support for software utilized throughout the division. This position focuses on testing and validation.\n\nEssential Functions:\n\u2022 Develop and conduct training of company personnel for the divisional software development and validation program.\n\u2022 Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.\n\u2022 Create and execute or direct software validation protocols traceable to system/software requirements.\n\u2022 Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.\n\u2022 Assist in the completion and maintenance of risk analysis, focused on software related risks.\n\u2022 Design and implement various product and process improvement methodologies (ie Six Sigma and Lean Manufacturing).\n\u2022 Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating, and resolving issues.\n\nQualifications:\n\u2022 BS degree in Engineering or Technical Field\n\u2022 2-5 years Software Quality Engineering experience.\n\u2022 Detailed knowledge of FDA, GMP, IEEE 1012 and ISO 13485\n\u2022 Solid communication and interpersonal skills\n\u2022 Advanced computer skills, including statistical/data analysis and report writing skills\n\u2022 Advanced Information Technology and data mining skills.\n\u2022 Prior medical device experience preferred\n\u2022 ASQ CSQE certification desired\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-18 19:27:23", "url": "http://jobs.sjm.com/xml/28797887/job", "country": "United States", "company": "St. Jude Medical", "title": "Software Quality Engineer II", "reqid": "12878", "state": "Minnesota", "state_short": "MN", "location": "Minnetonka, MN", "uid": 28797887}, {"country_short": "USA", "city": "Dallas", "description": "Sr. Quality Systems Engineer\nJob Requisition #: NMD3196\nDate Posted: 05/02/2012\nCategory: Engineering Quality\nLocation: Dallas - TX - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division:\n\nJob Overview\nWorking without appreciable supervision. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies advanced engineering and scientific principles to the evaluation and solution of technical problems. Initiates the planning, organizing, performing, coordinating and/or directing of engineering work. Performs engineering studies. Remains abreast of and consults on technical advancements. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.\n\nProvides quality system engineering support to site functions to ensure sub-system implementation complies with the NMD quality system requirements and governing regulations. This includes ensuring that system changes do not have an adverse effect on other sub-systems abilities to meet their requirements.  Provide project management duties of quality system improvement projects.\n\nMajor, On-Going Responsibilities:\n\u2022 Collaborate with cross functional management teams to define or improve quality system processes\n\u2022 Determine if organizational units are performing their defined processes and procedures in compliance with the NMD quality system and governing regulations, document deficient conditions\n\u2022 Act as Lead to plan, report on, follow-up and close scheduled and unscheduled quality system projects.\n\u2022 Obtain and analyze objective evidence as a basis for preparing an informed, objective report on the compliance of the process, discuss deficiencies and recommend corrective action, as requested.\n\u2022 Evaluate, or assist in evaluating, the adequacy of the corrective action to improve deficient conditions.\n\u2022 Perform or assists in the performance of special reviews as requested\n\nExperience and Training:\n\u2022 Bachelors degree Quality Engineering or related discipline\n\u2022 5-8 years of experience with quality systems engineering in a regulated (FDA) industry.\n\u2022 Knowledge of FDA CFR part 820, ISO 13485:2003, CMDCAS, AIMD\n\u2022 Project Management experience a plus\n\u2022 Excellent communication skills, including written, verbal and interpersonal\n\u2022 Excellent organization and administrative skills\n\u2022 Ability to work independently with minimal supervision\n\u2022 Takes initiative to perform tasks that benefit the organization\n\nOther Skills/Characteristics:\nEquipment: Computer keyboard; standard office equipment\nWorking Conditions: Normal office environment\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-02 18:54:00", "url": "http://jobs.sjm.com/xml/28332987/job", "country": "United States", "company": "St. Jude Medical", "title": "Sr. Quality Systems Engineer", "reqid": "NMD3196", "state": "Texas", "state_short": "TX", "location": "Dallas, TX", "uid": 28332987}, {"country_short": "USA", "city": "Minnetonka", "description": "Senior Engineer - Quality\nJob Requisition #: 13093\nDate Posted: 05/01/2012\nCategory: Engineering Quality\nLocation: Minnetonka - MN - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka.\n\nJob Overview\nPosition Summary:\nSenior Supplier Quality Engineer responsible for activities related to supplier selection and evaluation, material qualification, supplier performance and receiving inspection. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Cardiovascular Division and regulatory requirements. Primary responsibility is for plastics commodities.\n\nDuties and responsibilities:\n\u2022 Assesses supplier capabilities through direct visits, technical discussions, directed testing and quality system audits.\n\u2022 Manages development of supplied product inspection procedures and first article requirements.\n\u2022 Proactively communicates quality issues to suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions.\n\u2022 Contributes to the development, maintenance and improvement of CVD supplier quality program policies, procedures and forms.\n\u2022 Evaluates and develops Supplied Data Agreement partnerships with suppliers.\n\u2022 Provides engineering guidance to CVD Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures.\n\u2022 Applies sound engineering analysis and judgment to reduce the need for inspection in accordance to program policies.\n\u2022 Reviews and approves all supplied product drawings and component quality plans.\n\u2022 Works with Manufacturing engineering to assess and address purchased product issues.\n\u2022 Provides project direction, coaching, and mentoring for technical team personnel.\n\u2022 Provides guidance and training to Purchasing, R&D, Manufacturing and Quality engineers in applying program requirements.\n\u2022 Participates and provides engineering ownership for all supplied product Non-Conforming Material Reviews.\n\u2022 Contributes and participates in supplier performance reviews.\n\u2022 Participate in or lead teams in supporting Supplier Assurance program requirements (e.g., represent the Supplier Assurance function as a Core Team Member)\n\u2022 Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\u2022 Design and conduct experiments for process optimization and/or improvement\n\nMinimum Qualifications:\n\u2022 BS degree in Engineering or Technical Field\n\u2022 5+ years experience preferred\n\u2022 Previous Supplier Quality engineering experience and demonstrated use of Quality tools/methodologies.\n\u2022 Prior medical device experience preferred with detailed knowledge of FDA and ISO 13485 regulations\n\u2022 Plastics commodity expertise preferred (injection molding and extrusion)\n\u2022 Advanced computer skills, including statistical/data analysis and report writing skills\n\u2022 ASQ CQE and CQA certification preferred\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-05-01 19:14:54", "url": "http://jobs.sjm.com/xml/28305043/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Engineer - Quality", "reqid": "13093", "state": "Minnesota", "state_short": "MN", "location": "Minnetonka, MN", "uid": 28305043}, {"country_short": "USA", "city": "Dallas", "description": "Quality Engineer II\nJob Requisition #: NMD3188\nDate Posted: 04/25/2012\nCategory: Engineering Quality\nLocation: Dallas - TX - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division:\n\nJob Overview\nPosition Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.\n\nEssential Functions:\n\u2022 Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements\n\u2022 Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements\n\u2022 Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues\n\u2022 Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\u2022 Design and conduct experiments for process optimization and/or improvement\n\u2022 Appropriately document experiment plans and results, including protocol writing and reports\n\u2022 Lead process control and monitoring of Critical to Quality parameters and specifications\n\u2022 Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 Lead the investigation, resolution and prevention of product and process nonconformances\n\u2022 Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)\n\u2022 Lead in the completion and maintenance of risk analysis\n\u2022 Work with design engineering in the completion of product verification and validation\n\u2022 Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities\n\nOther Duties:\n\n\u2022 Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements\n\nAccountability/Supervision:\nSupervision will be from Senior or Principal Quality Engineers or Quality Manager\n\nRelationships:\nInternal: Manufacturing Engineering / Production Management / Regulatory Affairs / Product Surveillance / Design Assurance / Research and Development\nExternal: Suppliers\n\nEquipment: Equipment will be Quality Inspection equipment such as micrometers, tool scopes, vision systems, and tensile test systems.\n\nWorking Conditions: The work environment will be mixed between office environments to production shop floor. The production shop floor may include large heavy equipment in warehouse type environment to clean rooms with clean room gowning.\n\nPhysical Demands: Average eye-sight, ability to lift 20 lbs\n\nQualifications:\n\u2022 BS degree in Engineering or Technical Field; advanced degree preferred\n\u2022 2-5 years experience\n\u2022 Engineering experience and demonstrated use of Quality tools/methodologies\n\u2022 Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971\n\u2022 Solid communication and interpersonal skills\n\u2022 Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner\n\u2022 Advanced computer skills, including statistical/data analysis and report writing skills\n\u2022 Prior medical device experience preferred\n\u2022 Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 ASQ CQE or other certifications preferred\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-25 19:45:10", "url": "http://jobs.sjm.com/xml/28179860/job", "country": "United States", "company": "St. Jude Medical", "title": "Quality Engineer II", "reqid": "NMD3188", "state": "Texas", "state_short": "TX", "location": "Dallas, TX", "uid": 28179860}, {"country_short": "USA", "city": "Dallas", "description": "Senior Quality Engineer\nJob Requisition #: NMD3186\nDate Posted: 04/25/2012\nCategory: Engineering Quality\nLocation: Dallas - TX - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division:\n\nJob Overview\nPosition Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.\n\nEssential Functions:\n\u2022 Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements\n\u2022 Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements\n\u2022 Lead, coach, and mentor non-exempt and entry level exempt personnel\n\u2022 Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues\n\u2022 Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\u2022 Design and conduct experiments for process optimization and/or improvement\n\u2022 Appropriately document experiment plans and results, including protocol writing and reports\n\u2022 Lead process control and monitoring of Critical to Quality parameters and specifications\n\u2022 Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 Lead the investigation, resolution and prevention of product and process nonconformances\n\u2022 Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)\n\u2022 Lead in the completion and maintenance of risk analysis\n\u2022 Work with design engineering in the completion of product verification and validation\n\u2022 Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities\n\nOther Duties:\n\n\u2022 Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements\n\nAccountability/Supervision:.\nSupervision will be from Principal Quality Engineers or Quality Manager\n\nRelationships:\nInternal: Manufacturing Engineering / Production Management / Regulatory Affairs / Product Surveillance / Design Assurance / Research and Development\nExternal: Suppliers\n\nEquipment:\nEquipment will be Quality Inspection equipment such as micrometers, tool scopes, vision systems, and tensile test systems.\n\nWorking Conditions:\nThe work environment will be mixed between office environments to production shop floor. The production shop floor may include large heavy equipment in warehouse type environment to clean rooms with clean room gowning.\n\nPhysical Demands:\nAverage eye-sight, ability to lift 20 lbs\n\nQualifications:\n\u2022 BS degree in Engineering or Technical Field; advanced degree preferred\n\u2022 5+ years experience\n\u2022 Demonstrated supervisory experience preferred\n\u2022 Engineering experience and demonstrated use of Quality tools/methodologies\n\u2022 Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971\n\u2022 Solid communication and interpersonal skills\n\u2022 Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner\n\u2022 Advanced computer skills, including statistical/data analysis and report writing skills\n\u2022 Prior medical device experience preferred\n\u2022 Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 ASQ CQE or other certifications preferred\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-25 19:44:58", "url": "http://jobs.sjm.com/xml/28179857/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Quality Engineer", "reqid": "NMD3186", "state": "Texas", "state_short": "TX", "location": "Dallas, TX", "uid": 28179857}, {"country_short": "USA", "city": "Dallas", "description": "Senior Quality Engineer\nJob Requisition #: NMD3187\nDate Posted: 04/25/2012\nCategory: Engineering Quality\nLocation: Dallas - TX - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division:\n\nJob Overview\nPosition Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.\n\nEssential Functions:\n\u2022 Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements\n\u2022 Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements\n\u2022 Lead, coach, and mentor non-exempt and entry level exempt personnel\n\u2022 Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues\n\u2022 Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\u2022 Design and conduct experiments for process optimization and/or improvement\n\u2022 Appropriately document experiment plans and results, including protocol writing and reports\n\u2022 Lead process control and monitoring of Critical to Quality parameters and specifications\n\u2022 Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 Lead the investigation, resolution and prevention of product and process nonconformances\n\u2022 Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)\n\u2022 Lead in the completion and maintenance of risk analysis\n\u2022 Work with design engineering in the completion of product verification and validation\n\u2022 Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities\n\nOther Duties:\n\n\u2022 Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements\n\nAccountability/Supervision:.\nSupervision will be from Principal Quality Engineers or Quality Manager\n\nRelationships:\nInternal: Manufacturing Engineering / Production Management / Regulatory Affairs / Product Surveillance / Design Assurance / Research and Development\nExternal: Suppliers\n\nEquipment:\nEquipment will be Quality Inspection equipment such as micrometers, tool scopes, vision systems, and tensile test systems.\n\nWorking Conditions:\nThe work environment will be mixed between office environments to production shop floor. The production shop floor may include large heavy equipment in warehouse type environment to clean rooms with clean room gowning.\n\nPhysical Demands:\nAverage eye-sight, ability to lift 20 lbs\n\nQualifications:\n\u2022 BS degree in Engineering or Technical Field; advanced degree preferred\n\u2022 5+ years experience\n\u2022 Demonstrated supervisory experience preferred\n\u2022 Engineering experience and demonstrated use of Quality tools/methodologies\n\u2022 Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971\n\u2022 Solid communication and interpersonal skills\n\u2022 Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner\n\u2022 Advanced computer skills, including statistical/data analysis and report writing skills\n\u2022 Prior medical device experience preferred\n\u2022 Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 ASQ CQE or other certifications preferred\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-25 19:44:58", "url": "http://jobs.sjm.com/xml/28179858/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Quality Engineer", "reqid": "NMD3187", "state": "Texas", "state_short": "TX", "location": "Dallas, TX", "uid": 28179858}, {"country_short": "USA", "city": "Westford", "description": "Engineer Principal - Quality\nJob Requisition #: 13060\nDate Posted: 04/20/2012\nCategory: Process Development Engineering\nLocation: Westford - MA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA:\n\nJob Overview\nPosition Summary: This position is responsible for leading the development and maintenance of quality engineering methodologies and providing quality engineering subject matter expertise within new product development, manufacturing, or system/services support.\n\nEssential Functions:\n\u2022 Provides project direction, coaching, teaching, and mentoring for Quality engineering and technical team personnel.\n\u2022 Leads multifunctional teams in completing program directed or continuous improvement activities.\n\u2022 Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements\n\u2022 Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements\n\u2022 Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues\n\u2022 Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\u2022 Design and conduct experiments for process optimization and/or improvement\n\u2022 Appropriately document experiment plans and results, including protocol writing and reports\n\u2022 Lead process control and monitoring of CTQ parameters and specifications\n\u2022 Lead and implement various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 Lead the investigation, resolution and prevention of product and process nonconformances\n\u2022 Lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)\n\u2022 Lead in the completion and maintenance of risk analysis\n\u2022 Work with design engineering in the completion of product verification and validation\n\u2022 Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities\n\nOther Duties:\n\u2022 Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements\n\nAccountability/Supervision:.\nExpected to independently and effectively make data based decisions with respect to individual and project team deliverables. Able to independently perform core team member role. Able to manage and mentor technicians and lower levels of engineering.\nQualifications:\n\u2022 BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred\n\u2022 10+ years experience\n\u2022 Demonstrated supervisory experience\n\u2022 Engineering experience and demonstrated use of Quality tools/methodologies\n\u2022 Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971\n\u2022 Solid communication and interpersonal skills\n\u2022 Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner\n\u2022 Demonstrates technical leadership within the department and outside the department\n\u2022 Advanced computer skills, including statistical/data analysis and report writing skills\n\u2022 Prior medical device experience\n\u2022 Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 ASQ CQE or other certifications preferred\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-20 18:08:30", "url": "http://jobs.sjm.com/xml/28034677/job", "country": "United States", "company": "St. Jude Medical", "title": "Engineer Principal - Quality", "reqid": "13060", "state": "Massachusetts", "state_short": "MA", "location": "Westford, MA", "uid": 28034677}, {"country_short": "USA", "city": "Scottsdale", "description": "Senior Quality Engineer\nJob Requisition #: 13049\nDate Posted: 04/19/2012\nCategory: Quality\nLocation: Scottsdale - AZ - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in Scottsdale, Arizona:\n\nJob Overview\nThis is an exciting opportunity for a skilled quality engineer who is interested in building life saving devices while interacting with multiple sites across the U.S. and globally. Working within a small team, within the first 6 months on the role, the Senior QA engineer will come up to quick speed on the daily component and process issues that happen within the hybrid build process while providing guidance to the inspectors on visual criteria interpretation.\n\nOn a long term basis, the expectation is to have the engineer be fully integrated in the hybrid manufacturing culture while participating in activities and investigations related to our customers at other manufacturing sites (Sylmar, Puerto Rico, Malaysia and South Carolina). Will work closely with Engineering to define hybrid acceptance criteria for new components/ products; to create Quality plans for new products\n\nRequirements/Education: Bachelors Degree in Electrical or Mechanical Engineering. Minimum 5years of QA experience, working directly on a microelectronics manufacturing environment, solving day to day problems and dealing with people at all levels of the organization. Broad cross-disciplinary and in-depth knowledge of the quality engineering profession. A comprehensive familiarity with commodity and off-the-shelf electronic components. A qualified record of implementing new processes to existing design assurance and related systems. Requires comprehensive written and verbal communication, interpersonal, facilitation, presentation, quantitative, analytical, organizational, and follow-up skills, the ability to meet deadlines on multiple projects as well as the ability to converse effectively with all levels of employees. Documented record of delivering quality engineering information which adds value to managements decision making process. Demonstrated ability to understand and comply with applicable U.S. Food and Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and tasks. Advanced personal computer skills including spreadsheet, word processing database management, and specialized applications. Evaluation, originality, and/or ingenuity required.\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-19 18:48:23", "url": "http://jobs.sjm.com/xml/28008616/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Quality Engineer", "reqid": "13049", "state": "Arizona", "state_short": "AZ", "location": "Scottsdale, AZ", "uid": 28008616}, {"country_short": "USA", "city": null, "description": "Senior Quality Engineer\nJob Requisition #: 12975\nDate Posted: 04/13/2012\nCategory: Production\nLocation: Arecibo - - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management Division (CRMD):\n\nJob Overview\nThis position has a dual purpose (1) to ensure compliance to company/divisional policies and procedures and with FDA and ISO requirements by reviewing failures, complaints, defect reports, and audit findings in order to coordinate corrective action and (2) perform internal and vendor/supplier audits to determine such compliance. This position will have responsibility for quality compliance for all products produced in the SJM-PRLLC facility. This position works with minimum supervision and has appreciable latitude for interviewed actions. Assignments are broad in nature and employee uses discretion to design project task and to bring the project to completion.\n\nRequirements/Education: Bachelors degree in Engineering required, advanced degree or process towards advanced degree is a plus. Must have 4+ years experience in manufacturing, quality control, quality assurance, or regulatory compliance, preferably in the medical device or pharmaceutical industry. Must be knowledgeable of GMP and ISO evidenced by successful completion of training in GMP, auditing principals, and contamination control. Prior experience auditing FDA regulations preferred. Must be bilingual (English and Spanish), possess good communication and analytical skills, and availability to work under deadlines. Credentials of a Certified Quality Engineer are a plus. Must be able to apply comprehensive knowledge of a particular field of specialization to the completion of assigned task.\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-13 20:07:42", "url": "http://jobs.sjm.com/xml/27883013/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Quality Engineer", "reqid": "12975", "state": null, "state_short": null, "location": "Virtual, USA", "uid": 27883013}, {"country_short": "USA", "city": "St. Paul", "description": "Principal Quality Engineer\nJob Requisition #: 12790\nDate Posted: 04/02/2012\nCategory: Engineering\nLocation: St. Paul - MN - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in St. Paul:\n\nJob Overview\nThe Principal Quality Engineer is responsible for leading the development and maintenance of quality engineering methodologies and providing quality engineering subject matter expertise within manufacturing and system/services support.\n\nRequirements:\n\u2022 Provides project direction, coaching, teaching, and mentoring for Quality engineering and technical team personnel\n\u2022 Leads multifunctional teams in completing program directed or continuous improvement activities\n\u2022 Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements\n\u2022 Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements\n\u2022 Lead in the development and execution of streamlined business systems which effectively identify and resolve quality issues\n\u2022 Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\u2022 Design and conduct experiments for process optimization and/or improvement\n\u2022 Appropriately document experiment plans and results, including protocol writing and reports\n\u2022 Lead process control and monitoring of CTQ parameters and specifications\n\u2022 Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 Lead the investigation, resolution and prevention of product and process nonconformances\n\u2022 Lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)\n\u2022 Lead in the completion and maintenance of risk analysis\n\u2022 Work with design engineering in the completion of product verification and validation\n\u2022 Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities\n\nQualifications:\n\u2022 BS degree in Engineering or Technical Field; advanced degree preferred\n\u2022 8+ years experience\n\u2022 Demonstrated supervisory experience\n\u2022 Engineering experience and demonstrated use of Quality tools/methodologies\n\u2022 Must have experience with commercializing / validating new products\n\u2022 Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971\n\u2022 Solid communication and interpersonal skills\n\u2022 Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner\n\u2022 Demonstrates technical leadership within the department and outside the department\n\u2022 Advanced computer skills, including statistical/data analysis and report writing skills\n\u2022 Prior medical device experience\n\u2022 Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 ASQ CQE or other certifications preferred\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-04-03 03:22:30", "url": "http://jobs.sjm.com/xml/27603034/job", "country": "United States", "company": "St. Jude Medical", "title": "Principal Quality Engineer", "reqid": "12790", "state": "Minnesota", "state_short": "MN", "location": "St. Paul, MN", "uid": 27603034}, {"country_short": "USA", "city": "Westford", "description": "Engineer - Quality\nJob Requisition #: 12635\nDate Posted: 03/30/2012\nCategory: Engineering\nLocation: Westford - MA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA:\n\nJob Overview\nPosition Summary: This position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.\n\nEssential Functions:\n\u2022 Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements\n\u2022 Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements\n\u2022 Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues\n\u2022 Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\u2022 Design and conduct experiments for process optimization and/or improvement\n\u2022 Appropriately document experiment plans and results, including protocol writing and reports\n\u2022 Lead process control and monitoring of CTQ parameters and specifications\n\u2022 Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 Lead the investigation, resolution and prevention of product and process nonconformances\n\u2022 Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)\n\u2022 Lead in the completion and maintenance of risk analysis\n\u2022 Work with design engineering in the completion of product verification and validation\n\u2022 Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities\n\nQualifications:\n\u2022 BS degree in Engineering or Technical Field; advanced degree preferred\n\u2022 2-5 years experience\n\u2022 Engineering experience and demonstrated use of Quality tools/methodologies\n\u2022 Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971\n\u2022 Solid communication and interpersonal skills\n\u2022 Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner\n\u2022 Advanced computer skills, including statistical/data analysis and report writing skills\n\u2022 Prior medical device experience preferred\n\u2022 Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 ASQ CQE or other certifications preferred\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-03-31 03:43:28", "url": "http://jobs.sjm.com/xml/27532236/job", "country": "United States", "company": "St. Jude Medical", "title": "Engineer - Quality", "reqid": "12635", "state": "Massachusetts", "state_short": "MA", "location": "Westford, MA", "uid": 27532236}, {"country_short": "USA", "city": "Sylmar", "description": "Engineer, Principal Quality Assurance\nJob Requisition #: 12720\nDate Posted: 03/30/2012\nCategory: Quality\nLocation: Sylmar - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiac Rhythm Management business unit, located in the suburbs of Los Angeles:\n\nJob Overview\nWorking without appreciable direction, designs and delivers design assurance engineering products, or processes. Work requires the application of theoretical principles and creative/analytical techniques typically acquired in a recognized four-year or more academic course of study. Applies engineering and scientific principles to the evaluation and solution of technical problems. Exercises technical judgment in planning, organizing, performing, coordinating and/or directing engineering work. Performs engineering studies.\n\n- Strong QA leader with demonstrated experience in addressing quality system and technical issues.\n- A background in electromechanical class III medical devices\n- Mechanical or electrical engineering degree holder\n- Demonstrated ability to work with people from diverse cultures and work with individuals/teams at off shore locations\n- Good knowledge of quality system regulations, ISO13485, and risk management ISO 14971\n- Demonstrated ability to work with various levels of employees\n- A strong background in statistical techniques\n- Ability to critically analyze and improve upon existing procedures and develop new procedures as needed\n\nRequirements/Education: Bachelors Degree in Engineering (e.g., Electrical, Mechanical, Computer, etc.), or in a physical science, a related field, or equivalent. Typically a minimum of ten plus years of progressively more responsible work experience in a high technology manufacturing environment. Extensive knowledge and expertise at the forefront of the design assurance profession; applies, develops and promotes advanced concepts and practices; recognized authority in field. A comprehensive familiarity with commodity and off-the-shelf electronic components. A qualified record of implementing new processes to existing design assurance and related systems.\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-03-31 03:42:41", "url": "http://jobs.sjm.com/xml/27532214/job", "country": "United States", "company": "St. Jude Medical", "title": "Engineer, Principal Quality Assurance", "reqid": "12720", "state": "California", "state_short": "CA", "location": "Sylmar, CA", "uid": 27532214}, {"country_short": "USA", "city": "Irvine", "description": "Senior Design Quality Engineer\nJob Requisition #: AF13715\nDate Posted: 03/13/2012\nCategory: Engineering\nLocation: Irvine - CA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our our Atrial Fibrillation Division in Irvine, CA.\n\nJob Overview\nWe are seeking an experienced, high caliber, Design Quality Assurance Engineer to join our organization. This Senior Engineer partners with employees on cross functional teams focused on new product development. This DQE leads and ensures new product designs are in compliance in the following critical areas- marketing/user requirements, technical/engineering specifications, technical drawings, design verification and design validation test protocols and reports, risk analyses and reports, test method validations, equipment qualifications, and manufacturing procedures.\n\nImpact this role will have within the AF division:\n\u2022 Provide guidance to support completion of new product development quality deliverables: risk analyses and reports including FMEAs and Fault Tree Analyses; quality, shelf life, packaging, biocompatibility, and sterility assessments and plans; others.\n\u2022 Review and provide guidance on creation of new product development process deliverables, ensuring deliverables meet internal requirements: marketing/user requirements, technical/engineering specifications, technical drawings, design verification and validation test protocols and reports, risk analyses and reports, test method validations, equipment qualifications, manufacturing procedures, etc.. Work with process owners to develop procedures and work instructions for design control and new product development.\n\u2022 Ensure new product design compliance to internal Standard Operating Procedures (SOPs) and International Standards Organization 13485 and 21Code of Federal Regulations Part 820 Quality System Regulations. Ensure internal SOP compliance to external regulations.\n\u2022 Support and lead failure investigations including root cause analysis, correction, corrective/preventive actions, Design History File updates. Subject Matter Expert for failure investigation techniques and documentation.\n\u2022 Communicate any quality-related issues to Quality Management, propose and lead implementation of appropriate corrective actions. Prepare corrective action implementation project plan and schedule.\n\u2022 Subject Matter Expert for evaluation of effectiveness and safety of new product designs using understanding of the physiology and electrical systems of the human heart (including phenomena associated with atrial fibrillation), atrial fibrillation-related Electrophysiology (EP) lab procedures and equipment use cases, and knowledge of the design, function, and typical failure modes of devices manufactured by SJM-AFD.\n\nRequired Qualifications:\n\u2022 B.S. Engineering degree.\n\u2022 Extensive product and process validation experience.\n\u2022 Strong written and oral communication skills.\n\u2022 Successful track record of being organized, ability to prioritize, and working both independently and in teams.\n\u2022 Experience with new product development process through project completion under 21CFR Part 820 or Medical Device Directive regulations.\n\u2022 Understand and able to provide guidance regarding statistical decision-making (ANOVA, hypothesis testing, goodness-of-fit, etc.), data analysis (data types, accuracy vs. precision, mean/range/standard deviation), statistically sound sampling plans and acceptance criteria, measurement system analysis (Gauge R&R, capability), risk/hazard analysis techniques (FMEA/FMECA, FTA).\n\u2022 7+ years of QA experience within the medical device industry.\n\u2022 Experience with MS Word, MS Excel, MS Visio, Minitab.\n\u2022 Great reputation for leading and driving change on multiple projects.\n\u2022 Polished communicator- written documentation and oral presentations/ discussions/ meetings.\n\u2022 Excellent reputation for building relationships across various levels of an organization.\n\u2022 Organized, on-time, and detailed project management skills.\n\u2022 Energized attitude.\n\u2022 Ability to influence others without authority.\n\nPreferred Qualifications:\n\u2022 Preferred degrees are related to medical devices, such as Biomedical or Electrical Engineering degree.\n\u2022 CQE, CQA certification.\n\nTo learn more, visit our web site at www.sjm.com\nSt. Jude Medical is an equal opportunity employer.\n\n\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-03-13 23:44:27", "url": "http://jobs.sjm.com/xml/27117043/job", "country": "United States", "company": "St. Jude Medical", "title": "Senior Design Quality Engineer", "reqid": "AF13715", "state": "California", "state_short": "CA", "location": "Irvine, CA", "uid": 27117043}, {"country_short": "USA", "city": "Westford", "description": "Engineer - Quality\nJob Requisition #: 12565\nDate Posted: 02/24/2012\nCategory: Engineering Quality\nLocation: Westford - MA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA:\n\nJob Overview\nPosition Summary:\nThis position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.\n\nEssential Functions:\n\u2022 Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements\n\u2022 Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements\n\u2022 Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues\n\u2022 Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\u2022 Design and conduct experiments for process optimization and/or improvement\n\u2022 Appropriately document experiment plans and results, including protocol writing and reports\n\u2022 Lead process control and monitoring of CTQ parameters and specifications\n\u2022 Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 Lead the investigation, resolution and prevention of product and process nonconformances\n\u2022 Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)\n\u2022 Lead in the completion and maintenance of risk analysis\n\u2022 Work with design engineering in the completion of product verification and validation\n\n\nQualifications:\n\u2022 BS degree in Engineering or Technical Field; advanced degree preferred\n\u2022 2-5 years experience\n\u2022 Engineering experience and demonstrated use of Quality tools/methodologies\n\u2022 Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971\n\u2022 Solid communication and interpersonal skills\n\u2022 Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner\n\u2022 Advanced computer skills, including statistical/data analysis and report writing skills\n\u2022 Prior medical device experience preferred\n\u2022 Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 ASQ CQE or other certifications preferred\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-02-27 23:58:45", "url": "http://jobs.sjm.com/xml/26798151/job", "country": "United States", "company": "St. Jude Medical", "title": "Engineer - Quality", "reqid": "12565", "state": "Massachusetts", "state_short": "MA", "location": "Westford, MA", "uid": 26798151}, {"country_short": "USA", "city": "Westford", "description": "Engineer II - Quality\nJob Requisition #: 12344\nDate Posted: 02/21/2012\nCategory: Engineering Quality\nLocation: Westford - MA - USA\n\n\nAbout Us\nOur teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life?\n\n\n\nWe are an Equal Opportunity/Affirmative Action Employer. We currently have this position open at our Cardiovascular Division at LightLab Imaging Inc., a St Jude Medical Company, based in Westford MA:\n\nJob Overview\nPosition Summary:\nThis position is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within remanufacturing/Service\n\nEssential Functions:\n\u2022 Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements\n\u2022 Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements\n\u2022 Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues\n\u2022 Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues\n\u2022 Design and conduct experiments for process optimization and/or improvement\n\u2022 Appropriately document experiment plans and results, including protocol writing and reports\n\u2022 Lead process control and monitoring of CTQ parameters and specifications\n\u2022 Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 Lead the investigation, resolution and prevention of product and process nonconformances\n\u2022 Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)\n\u2022 Lead in the completion and maintenance of risk analysis\n\u2022 Work with design engineering in the completion of product verification and validation\n\n\nQualifications:\n\u2022 BS degree in Engineering or Technical Field; advanced degree preferred\n\u2022 2-5 years experience\n\u2022 Engineering experience and demonstrated use of Quality tools/methodologies\n\u2022 Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971\n\u2022 Solid communication and interpersonal skills\n\u2022 Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner\n\u2022 Advanced computer skills, including statistical/data analysis and report writing skills\n\u2022 Prior medical device experience preferred\n\u2022 Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)\n\u2022 ASQ CQE or other certifications preferred\n\n\n\n|E-mail this position \nSubmit Resume or C.V.", "date_new": "2012-02-21 21:40:43", "url": "http://jobs.sjm.com/xml/26658112/job", "country": "United States", "company": "St. Jude Medical", "title": "Engineer II - Quality", "reqid": "12344", "state": "Massachusetts", "state_short": "MA", "location": "Westford, MA", "uid": 26658112}]