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 ISO 13485 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
Benefits
- Competitive compensation based on experience and qualifications
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
