Supplier Quality Engineer

JOB TYPE: Full Time, Employee JOB CATEGORY: Engineering CITY: Danvers STATE: MAAbout Medtronic Benefits and Total Rewards It's challenging. It's energizing. It's rewarding. That's why our nearly 38,000 employees have chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 10 years. Supplier Quality Engineer Req. # 63430Position Description Provide comprehensive support to Development and Operations and outsourcing Teams in all areas of design control and production quality assurance.  Actively participate in definition of test requirements, acceptance limits and sampling plans to ensure compliance with Medtronic, FDA and international requirements @ supplier locations. Position Responsibilities • Provide oversight and monitoring to suppliers as required. • Provide technical support to project teams.  Interface with other functional areas, primarily Engineering, in areas such as preparing test plans, data analysis, specifications, risk analysis, implementing changes and process validations. • Prepare Commercial Release packages • Participate in cross-functional and/or departmental team projects • Coordinate Accelerated Aging activities • Act as QA representative on the material review board (MRB).  Investigate causes of quality and yield issues.  Interface with other functional groups in resolving those issues. • Provide day-to-day troubleshooting and resolve immediate problems @ suppliers. • Provide engineering support/analysis in the evaluation of customer complaints • Review and approve protocols, procedures and specifications • Perform supplier audits for compliance at supplier locations • Act as liaison to vendors relative to quality issues • Prepare weekly reports • Perform all responsibilities with the achievement of Customer Focused Quality as the primary priority and goal. • May involve supervision/guidance/training of inspectors/technicians • Perform other related tasks as needed. Basic Qualifications • Bachelor’s degree in engineering discipline • Working knowledge of process validation, design of experiments, vendor and internal auditing, statistical quality control, biocompatibility, protocol/report preparation and material review board. • Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003 • Minimum 2 to 4 years quality assurance experience in a GMP environment or highly regulated industry with BS Degree. Minimum 0 to 2 years experience with Masters Degree. • Experience working in a team environment. Desired/Preferred Qualifications • ASQC certification. • Masters degree in engineering, science or math. • 4 or more years of quality assurance experience in a GMP, disposable medical device environment. • Guide wire/guide catheter experience and familiarity with medical device regulatory requirements. • Effective verbal and written communication, analytical, influencing and interpersonal skills. • Must be able to communicate at all levels and across company lines. • PC skills, word processing, spreadsheets, project management, etc. • Basic Statistical Knowledge and Application Physical Job Requirements • Sit/stand for 8 hours. • Some travel.   To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an equal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/careers   Click here to see other Medtronic opportunities  Email this Job to a Friend