Quality Inspector

About the role

The Quality Inspector ensures that all incoming materials, in‑process components, and finished medical devices meet strict quality standards. Working in a cleanroom environment, the role involves visual and dimensional inspections, data recording, and coordination with production and suppliers.

Key responsibilities

• Perform receiving inspections on raw materials, packing materials, and components according to specifications.
• Monitor key process inputs and variables, communicating adjustments to production personnel.
• Conduct in‑process and final inspections of molded parts, sub‑assemblies, and finished devices.
• Reject, label, and quarantine non‑conforming items and report findings to the supervisor.
• Participate in new product development, process validation, and first‑article inspections.
• Maintain and calibrate critical measuring equipment and ensure proper documentation in Device History Records.
• Support root‑cause investigations, corrective actions, and customer complaint handling.

Required profile

• Ability to stand, walk, and sit for extended periods in a cleanroom.
• Willingness to work night shifts and weekends as needed.
• Strong mechanical aptitude and analytical mindset for troubleshooting and process improvement.

Required skills

• Quality inspection of plastics injection‑molded medical devices.
• Knowledge of Quality Management Systems, preferably ISO 13485.
• Proficiency with Minitab and Microsoft Office suite (Word, Excel, PowerPoint, Outlook).
• Experience with dimensional measurement, calibration, and use of custom gauges.