New Bedford, MA
Tremendous contract to perm opportunity in the New Bedford area for a Quality Engineer to help develop, execute and document new manufacturing processes with a hands on approach in a team setting!
- Must have Strong IQ, OQ, and PQ experience.
- Someone with a strong manufacturing engineering or manufacturing quality engineering background.
- Medical experience needed.
- Experience with manufactured parts that are metal formed or machined. Injection molding is also good.
- 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
- Qualified Local Candidates encouraged to apply!
• Multiple Healthcare Plans
• Accident, Disability, Life
• Direct Deposit/Pay Cards
• Referral Bonuses
if interested please send resume to: email@example.com