New Bedford, MA
Our client in the New Bedford area has an excellent opportunity for a temp to hire Quality Engineer to help develop, execute and document new manufacturing processes with a hands on approach in a team setting.
- Position requires strong IQ, OQ, and PQ experience.
- Strong manufacturing engineering or manufacturing quality engineering background.
- Medical experience is a must
- Experience with manufactured parts that are metal formed or machined.
- Injection molding is also preferred.
- Process Excellence/Lean experience
- Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
- Strong background in Process Qualification (IQ / OQ / PQ Methodology) including special processes.
- Strong analytical, writing background
- Skilled in statistical methods and design of experiments
- Fluent in Blueprint reading/literacy including GD&T
- Proficient in developing detailed work instructions
- Experience utilizing standard root cause analysis tools
- Experience conducting Process Failure Mode Effects and Analysis
- Experience generating Control Plans
- Experience with test methods and standards for the validation of manufacturing of medical device products
- Experience developing visual attribute test methods
- LOCAL applicants only please
- Multiple Healthcare Plans
- Accident, Disability, Life
- Direct Deposit/Pay Cards
- Referral Bonuses
if interested please send resume to: firstname.lastname@example.org