Senior Quality Engineer #22000O60
Senior Quality Engineer, Covidien LP (a Medtronic company), North Haven, CT. Multiple positions available. Master’s degree in Technology Management, Mechanical, Electrical, Industrial, or Biomedical Engineering or related field and two (2) years of experience as a Quality Engineer or in Quality Engineering. Experience must include a minimum of two (2) years of each of the following: Quality Engineering for medical device components meeting specifications; 21 CFR Part 820 Quality System Regulation (QSR), ISO 13485, European Union (EU) Medical Device Regulation (MDR), State of the Art (SOTA) and Good Manufacturing Practices (GMP); Risk Assessments, Preliminary Hazard Analysis (PHA) and PFMEA; Non-Conformances, Complaints and Corrective and Preventive Actions (CAPA); Process Improvement Tool DMAIC, Root Cause Analysis, 5Whys, Fishbone and cause mapping; Design of Experiments (DOE) methods to establish process development; and Development of V&V (verification and validation), IQ, OQ, and PQ
Covidien/Medtronic are equal opportunity employers committed to cultural diversity in the workplace. All individuals are encouraged to apply.