[{"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": "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": "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}]