Analysis Skills, Calibration, Communication Skills, Continuous Improvement, Contract Manufacturing, Corporate Policies, Corrective Action, Cross-Functional, Data Analysis, Data Quality, Document Control, FDA (Food and Drug Administration), High School Diploma, ISO (International Organization for Standardization), Manufacturing/Industrial Processes, Medical Equipment, Mentoring, Onboarding, Process Improvement, Process Validation, Quality Assurance Methodology, Quality Engineering, Six Sigma Green Belt, Support Documentation, Technical Leadership, Technical Writing, Time Management, Training/Teaching, Writing Skills
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.
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
Required Qualifications:
- 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.
Compensation:
The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $22.88 - 36.54/hr.
For temp, temp-to-hire, and regular full-time positions, our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.