Piper Companies is currently looking for a consulting Supplier Quality Engineer in West Chester, PA to join an innovative player in the orthopedic industry to provide quality assurance leadership in manufacturing sites and raw material suppliers engaged in production of manufactured goods.
The consultant will support a multi year project team to bring devices compliant with new EUMDR regulations.
Responsibilities of the Supplier Quality Engineer include:
- Conduct audits to good manufacturing practices and provide team support for quality system design and audit
- Address and correct product/process complaints and report on contract manufacturers performance metrics
- Ensure comprehensiveness measurement systems to monitor effectiveness of quality and reliability systems to identify, bracket, correct, and prevent defects
- Provide quality engineering support to suppliers including audits/assessments, inspection technique support, validation activities, CAPA, and change controls management
Qualifications for the Supplier Quality Engineer:
- 4+ years of cGMP/ISO pharmaceutical/medical device industry experience
- Working knowledge of medical devices and manufacturing process
- FDR CFR Part 82/ISO 13485
- Bachelor's Degree in Engineering, Life Sciences, or related field required; Six Sigma/ASQ Certification is a plus
Compensation for the Supplier Quality Engineer position includes:
- Commensurate to experience
- Full Benefits: Healthcare, Dental, VSP Vision, 401k option