Quality Inspector I

About the role

CooperSurgical is seeking a Quality Inspector I to join its manufacturing team. The role focuses on ensuring that incoming materials, in‑process components, and finished medical devices meet strict quality and regulatory standards.

Key responsibilities

• Perform visual, dimensional, and functional inspections using calibrated measuring instruments such as calipers, micrometers, and gauges.
• Review Device History Records, batch records, and other quality documentation for completeness and compliance.
• Identify, document, and escalate non‑conforming materials or products, supporting segregation and containment activities.
• Initiate and support non‑conformance reports (NCMRs) and assist in investigations.
• Conduct in‑process and final audits to verify adherence to manufacturing procedures and quality standards.
• Record inspection and test results in electronic or paper systems following Good Documentation Practices.
• Support line clearance activities and verify readiness for production runs.
• Collaborate with Manufacturing, Engineering, and Quality Engineering to resolve quality issues and drive continuous improvement.
• Maintain compliance with FDA 21 CFR Part 820, ISO 13485, GMP, and internal procedures.
• Ensure inspection equipment is calibrated and maintain cleanroom and contamination control practices.

Required profile

• Working knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Familiarity with FDA 21 CFR Part 820 and ISO 13485 standards (preferred).
• Ability to read and interpret engineering drawings, specifications, and procedures.
• Attention to detail and strong documentation skills.

Required skills

• Use of calibrated measuring instruments (calipers, micrometers, gauges).
• Test equipment operation.
• Knowledge of FDA 21 CFR Part 820.
• Knowledge of ISO 13485.
• Understanding of GMP and GDP.