Sr. Quality Engineer at Medtronic in North Haven, Connecticut

Job Description:

Position Description:

Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in North Haven, CT. Responsible for supporting a range of Medtronic Minimally Invasive Therapy Group (MITG) medical device products, including Polysorb and V-Loc Wound Closure Device, the worldwide market-leading braided and barbed suture technology, and other wound closure devices. Responsible for products in the form of finished medical devices within the Surgical Innovation Business Unit by supporting manufacturing operations, evaluating compliance of materials and processes with specifications, and customer requirements in compliance. Coordinates Quality Engineering for medical device components, ensuring that all finished good and processes meet specifications. Navigates the complexity of government and industry regulations to include 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). Responsible for Risk Assessments, Preliminary Hazard Analysis (PHA) and PFMEA. Non-Conformances, Complaints and Corrective and Preventive Actions (CAPA). Leverages Process Improvement Tools to include DMAIC, Root Cause Analysis, 5Whys, Fishbone and cause mapping. Leverages Design of Experiments (DOE) methods to establish process development as well as Statistical analysis tools for process capability (Cpk/Ppk), Analysis of Variance (ANOVA), Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis and Test Method Validation (TMV). Works on the development of V&V (verification and validation) using IQ, OQ, and PQ. Multiple positions available.

Basic Qualifications:

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.