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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 9001, ISO 13485 and 21 CFR 820 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 years 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
- 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
- Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.
Work Type
- Full-time
Experience Level
- Senior
Education Level
- High school diploma or equivalent
- Associate degree or equivalent
Salary/Compensations
- $22 - $36/hr
About the Company
- Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry.
- With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture.
- Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.
- Join Resonetics and be part of a team that’s redefining medical device manufacturing.
- If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.