Senior Quality Engineering Technician
About The Position
The Senior Quality Engineering Technician provides advanced customer- and factory-facing quality support for contract manufacturing of medical device components. This role serves as a key technical resource in the transition, validation, and sustaining of Nitinol manufacturing processes, with increased ownership of quality systems, data-driven decision-making, and cross-functional support. The Senior Quality Engineering Technician operates with a high degree of independence and is expected to lead routine quality activities, mentor junior technicians and operations personnel, and drive improvements aligned with ISO 9001, ISO 13485 and 21 CFR 820 requirements.
Requirements
- High school diploma or equivalent
- Minimum 3 year experience in a quality role such as inspector, analyst, technician, etc.
- Demonstrated technical writing and communication skills.
- Proven ability to work independently and lead technical tasks
Nice To Haves
- Associate degree or equivalent
- 5+ 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
Responsibilities
- Own and drive timely processing of Nonconformances, Process Deviations, and other quality records
- Maintaining calibration program
- Maintaining control plans/pFMEAs
- React to leading indicators in facilitation of preventive action execution
- Support document control activities
- Support Gage R&R completion and Test Method Validations
- Support Corrective and Preventive Actions
- Support continuous improvement projects
- Support process validation activities, including protocol execution and data analysis
- Perform and/or oversee sample preparation and testing (Tensile, BFR, DSC, Chemical), ensuring data integrity and accuracy
- Lead inspection activities and decision-making for mill products (Bar, Coil, Wire, Thick Sheet), including disposition recommendations
- Author and revise quality procedures
- Conducting training, including onboarding of new employees
- Other duties as necessary
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
