The Quality Engineer Technician provides customer and factory-facing quality support for contract manufacturing of medical device components. The position includes assisting with transition and sustaining of micromanufacturing processes, and support for supplier quality management.
The Quality Engineer Technician position supports 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.
- Coordinating timely processing of Nonconformances, Process Deviations, and other quality records
- Maintaining calibration program
- Maintaining control plans/pFMEAs
- Supporting document control activities
- Supporting Gage R&R facilitation
- Supporting Corrective and Preventive Actions
- Supporting continuous improvement projects
- Assisting with troubleshooting of production processes
- Revising quality procedures
- Conducting training, including onboarding of new employees
- Other duties as necessary
- High school diploma or equivalent
- Minimum 1 year experience in a quality role such as inspector, analyst, technician, etc.
- Demonstrated technical writing and communication skills.
- Associate degree or equivalent
- 2 years experience in a Quality Engineering Technician role for a medical device manufacturer or equivalent experience
- Familiarity with ISO and FDA compliance
- Six Sigma Green Belt
- Primarily light office work
- May involve bending and lifting of light to medium weight objects.