Senior Quality Engineering Technician
About the role
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 13485 requirements.
Responsibilities
- Own and drive timely processing of Nonconformances, Process Deviations, and other quality records
- Maintain calibration program
- Maintain 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
- Conduct training, including onboarding of new employees
- Other duties as necessary
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
Preferred Qualifications
- 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
Physical Demands
- Primarily light office work
- May involve bending and lifting of light to medium weight objects
Pay
The anticipated range is $22.88 - $36.54/hr, based on experience and qualifications.
Schedule
2nd shift: 2pm–10pm, Monday–Friday
Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.