Quality Control Engineer – QC Lab & Validation

About the role

CooperSurgical is seeking a Quality Control Engineer to lead qualification and validation activities for a new state‑of‑the‑art manufacturing facility in Alajuela, Costa Rica. You will become the technical expert for all QC equipment, supporting technicians during method validations and routine testing.

Key responsibilities

• Plan, execute, and document qualification and validation protocols (IQ, OQ, PQ) for analytical equipment.
• Develop and validate laboratory test methods, writing protocols and final reports.
• Manage lab equipment maintenance contracts, calibrations, repairs, and asset tracking.
• Troubleshoot equipment and process deviations, perform root‑cause analysis, and resolve alarms.
• Monitor testing trends, review and approve release results for raw materials and finished products.
• Support audit readiness, ensure compliance with GMP, ISO, FDA, and OSHA regulations.
• Collaborate with manufacturing engineering to transfer QC methods and equipment.
• Conduct investigations (OOS, NCMR, CAPA, environmental monitoring) and integrate SOPs into the quality management system.

Required profile

• Bachelor’s degree in biomedical engineering, bioprocess, biotechnology, microbiology, chemical engineering or a related field.
• Minimum 3 years of experience in quality control, equipment qualification, and method validation within the medical‑device industry.

Required skills

• IQ, OQ, PQ qualification procedures
• Method development and validation
• Equipment maintenance and calibration management
• Root‑cause analysis and troubleshooting
• GMP, ISO, FDA, OSHA compliance
• OOS, NCMR, CAPA investigations
• Environmental monitoring

What we offer

• Opportunity to work in a cutting‑edge manufacturing facility.
• Collaborative, cross‑functional environment.
• Professional development in medical‑device quality engineering.