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Form of workJob Description
A leading medical device company, is seeking an experienced Quality Control Engineer to join their team. The successful candidate will be responsible for driving Continuous Improvement and developing quality metrics to ensure the highest standards of quality output.
Key Responsibilities:
- Supporting Quality Control in containment, investigation and resolution of non-conformances.
- Maintaining nonconforming database and supporting equipment calibration.
- Leading lean thinking, team involvement and problem solving to improve quality output.
- Evaluating and analyzing current quality metrics and feedback to target and reduce quality defects.
- Collecting production data, analyzing outputs, and determining corrective courses of action to promote quality and efficiency.
- Working with management to drive Continuous Improvement and assist in the development of Quality Metrics.
- Developing, implementing, and managing Quality Control/Quality System process improvements.
Key Qualifications:
- BS in mechanical engineering discipline; plus, 1-2 years' experience in an FDA/ISO regulated Medical Device industry
- 5+ years of experience in a Quality Engineering role
- CAPA and MRB experience
- Six Sigma, Lean Concepts, 8D Problem Solving experience
- SPC, basic statistical tests experience
- Mechanical drawing, GD&T experience
- DFMEA and PFMEA experience
Job Responsibilities:
•Conducting Post Market Activities and Post Market Surveillance
•Managing Customer and Product Complaint Investigation programs
Education and Experience:
•1 YR. of experience in a technical role in the medical device/pharma/biotech industry
•Bachelor's degree
•Computer proficiency
