Sr. Quality Ops Engineer
Sr. Quality Ops Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- 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 Im 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.
- Bachelors 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).
- Handson 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.
Employment Type
Full Time
