Quality Technician

About the role

The Quality Technician assists in administration of quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. The role supports manufacturing and servicing operations by performing and documenting problem‑solving investigations, conducting in‑process sub‑assembly and final QC product acceptance testing, identifying and documenting process and product non‑conformances, reviewing device history records, authorizing release of finished product/processes, executing calibration and environmental monitoring processes. Location: 41905 28th Ave North Plymouth, MN. Hire type: Direct, full‑time.

Responsibilities

• Assists in production line Quality investigations and associated problem‑solving activities.
• May coordinate and conduct 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 DHR’s 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.

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.
• Ability to work in a fast‑paced environment with strict deadlines.
• Generate detailed, high‑quality documentation.
• Work with others in analyzing and solving technical problems.
• PC experience and working familiarity of common desktop applications including Excel and Word.
• Experience with mathematical skills including