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Quality Engineer
Nashua, NH 03061 US
Job Description
quality support for contract manufacturing of medical device components.
The Quality Engineer position uses Quality Engineering techniques including: Problem solving using Lean Six Sigma methodology, Process Validations, Process Development and optimization, Gage R&R, reducing dependence on inspection, ISO 13485 and/or 21CFR820 compliance.
Responsibilities
- Liaising with customer quality personnel to resolve issues and Customer Complaints
- Monitoring and disseminating customer quality report cards
- Generating process deviations, Customer Change Notices, validation protocols & reports.
- Assisting with troubleshooting of production processes Assisting with the PDP process
- Leading development of metrology equipment
- Developing and maintaining quality/control plans
- Developing PFMECAs
- Conducting Gage R&R studies
- Resolving Corrective and Preventive Actions
- Developing Quality Procedures and conducting training to all personnel as appropriate
- Approving Nonconformance disposition
- Analyzing production and validation data
- Minimum 2 years' experience in a Quality Engineering role for a medical device manufacturer and/or startup company, or equivalent engineering experience
- Working knowledge of Statistical software and/or Minitab
- Bachelor's degree or equivalent experience
- CQE and/or Six Sigma Green or Black belt
- BS degree; Physics, Optics, Mechanical, Chemical, Plastics preferred
Meet Your Recruiter
John Ellison
John has 30 years of experience recruiting professionals in the high-tech space. He possesses strong knowledge of recruiting strategies for permanent and contract placement. Additionally, he has 11 years of direct client interface sales and marketing experience for the staffing industry.
