Engineer - Quality
Job Requisition #: 12017
Date Posted: 12/01/2011
Category: Engineering
Location: Minnetonka - MN - USA
About Us
St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.
We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in Minnetonka.
Job Overview
Position 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.
Essential Functions:
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
Lead in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements
Assist in the development and execution of streamlined business systems which effectively identify and resolve quality issues
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Design and conduct experiments for process optimization and/or improvement
Appropriately document experiment plans and results, including protocol writing and reports
Lead process control and monitoring of CTQ parameters and specifications
Lead and implement various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)
Lead the investigation, resolution and prevention of product and process nonconformances
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Lead in the completion and maintenance of risk analysis
Work with design engineering in the completion of product verification and validation
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
Qualifications:
BS degree in Engineering or Technical Field; advanced degree preferred
2-5 years experience
Engineering experience and demonstrated use of Quality tools/methodologies
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971
Solid communication and interpersonal skills
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
Advanced computer skills, including statistical/data analysis and report writing skills
Prior medical device experience preferred
Experience implementing various product and process improvement methodoligies (e.g., Six Sigma and Lean Manufacturing)
ASQ CQE or other certifications preferred
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