Quality Control Engineer I

About the role

CooperSurgical is seeking a Quality Control Engineer I to support qualification and validation activities in its QC laboratory. The role focuses on ensuring analytical equipment and processes meet approved protocols, timelines, and regulatory standards.

Key responsibilities

• Assist in protocol preparation, data collection, and report generation for analytical equipment.
• Execute laboratory testing for method development and validation under supervision.
• Maintain equipment records, calibration schedules, and coordinate maintenance and re‑qualification.
• Participate in troubleshooting, root‑cause investigations, and equipment alarm monitoring.
• Monitor and trend testing data, preparing summaries for senior review.
• Collaborate with QC technicians and other departments to support routine operations and escalate technical issues.
• Perform preliminary data reviews to ensure completeness before formal approval.
• Support audit readiness, SOP preparation, and compliance with GMP, ISO, FDA regulations.
• Conduct investigations for OOS, NCMR, CAPA, out‑of‑tolerance results, and environmental monitoring excursions.

Required profile

• Basic understanding of analytical techniques and laboratory equipment.
• Familiarity with GMP, ISO, FDA, and OSHA quality and safety standards.
• Ability to document investigations and maintain accurate records.
• Strong attention to detail and ability to work cross‑functionally.

Required skills

• Analytical techniques
• Laboratory equipment operation