Katalyst Healthcares and Life Sciences
Responsibilities:
- Looking for a senior operations quality engineer for six months from the beginning of June. The scope of work for this role is to support the current senior operations quality engineer on a product transfer project from another site to this facility. Specifically, I'm looking for a person who can,
- Review risk management files (pFMEA).
- Review process validation protocols and reports.
- Draft/update the master validation plan.
- Review manufacturing process instructions.
- Draft quality inspection procedures.
- Review equipment introduction, calibration, and PM records.
- Bachelor's degree in engineering (Mechanical, Biomedical, Industrial, or related field) or equivalent experience.
- 5+ years of quality engineering experience in a medical device manufacturing environment (Class II preferred).
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971 (Risk Management), and ISO 14644 (Cleanrooms).
- Hands-on experience with CAPA, NCMR investigations, root cause analysis, and statistical process control (SPC).
- Proficiency in Process Validation (IQ, OQ, PQ), Gage R&R, and AQL sampling plans.
- Ability to interpret engineering drawings, GD&T, and work with metrology tools (calipers, micrometers, CMM).
- Prior BMRAM and Propel experience is a plus.