Overview
Senior Quality Engineer Jobs in Newton, USA at S4 Analytics LLC
Leads development of operational quality controls for legacy manufacturing processes by translating ISO 14971 risk management outputs and historical design documentation into PFMEAs, Control Plans, inspection strategies, and validation activities.
Responsibilities
- Review ISO 14971 Risk Management Reports to identify hazards, CTQs, and required controls
- Develop PFMEAs for legacy manufacturing processes
- Translate PFMEA outputs into Control Plans
- Ensure CTQs are controlled through incoming, in‑process, and final inspection
- Write, review, and approve IQ/OQ/PQ and TMV documentation
- Lead CAPA investigations and effectiveness checks
- Apply statistical tools (Six Sigma, SPC, DOE)
Qualifications
- BS or MS in Mechanical, Biomedical, Industrial, or Electrical Engineering
- 10+ years Quality Engineering experience in medical devices or regulated manufacturing
- Strong knowledge of 21 CFR, ISO 13485, ISO 14971, IVDR
Required Skills
- Strong knowledge of 21 CFR, ISO 13485, ISO 14971, IVDR
Preferred Skills
- 10+ years Quality Engineering experience in medical devices or regulated manufacturing.
#J-18808-Ljbffr
Title: Senior Quality Engineer
Company: S4 Analytics LLC
Location: Newton, USA
Category:
