Quality Technician
About the Role
The Quality Technician assists in administering quality functions at a site to ensure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable regulatory standards. This role supports manufacturing and servicing operations by performing and documenting problem-solving investigations, conducting in-process sub-assembly and final QC product acceptance testing, and identifying and documenting process and product non-conformances.
Responsibilities
- Assists in production line Quality investigations and associated problem-solving activities.
- Coordinates and conducts in-process and final QC product acceptance testing, depending on facility.
- Investigates production line stoppages to identify corrective actions.
- Identifies and documents product and process non-conformances.
- Participates on a Material Review Board to review and process non-conformance reports.
- Reviews Device History Records (DHRs) and supports batch record release.
- Enters and retrieves Quality data from local and global systems.
- Performs site calibration activities and recordkeeping.
- Executes environmental monitoring processes and recordkeeping.
- Verifies calculations, dose ranges, dosimeter placements, and special instructions prior to processing and as part of final product release.
- Completes other duties as assigned.
Requirements
- Minimum of three (3) years of experience in a manufacturing or repair environment or other technical production tasks with a high school diploma or equivalent.
- Minimum of one (1) year of experience in a manufacturing or repair environment or other technical production tasks with an Associate Degree.
- Experience with mathematical skills including ratios, proportions, and basic algebra.
Benefits
- Market competitive pay.
- Extensive paid time off and nine (9) added holidays.
- Excellent healthcare, dental, and vision benefits.
- Long/short-term disability coverage.
- 401(k) with a company match.
- Maternity and paternity leave.
- Additional add-on benefits/discounts for programs such as pet insurance.
- Tuition reimbursement and continued education programs.
- Excellent opportunities for advancement in a stable, long-term career.
- Climate-controlled facilities.
- Tools provided.
Pay
Pay range for this opportunity is $21.50 per hour. This position is eligible for bonus participation. Minimum pay rates offered will comply with county/city minimums, if higher than the range listed. Pay rates are based on factors including local labor market costs, years of relevant experience, education, professional certifications, and foreign language fluency.