Quality Control Engineer I

About the role

CooperSurgical is seeking a Quality Control Engineer I to support qualification, validation, and routine laboratory activities within its QC laboratory. The role involves hands‑on work with analytical equipment, data collection, and ensuring compliance with regulatory standards.

Key responsibilities

• Support execution of qualification and validation activities according to approved protocols.
• Assist with protocol preparation, data collection, and report generation for analytical equipment.
• Maintain equipment records, calibration schedules, and coordinate routine maintenance and re‑qualification.
• Participate in troubleshooting, root‑cause investigations, and equipment alarm monitoring.
• Monitor and trend laboratory testing data, preparing summaries for senior review.
• Perform preliminary data reviews to ensure completeness and accuracy.
• Support audit readiness, GMP, ISO, and FDA compliance activities.
• Assist in transferring QC methods and equipment to production environments.
• Develop and revise SOPs within the quality management system.
• 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 calibration, maintenance, and equipment qualification processes.
• Ability to document investigations and follow regulatory requirements (GMP, ISO, FDA, OSHA).
• Detail‑oriented with strong organizational skills.

Required skills

• Analytical equipment operation
• Calibration and maintenance of laboratory instruments
• Root‑cause investigation
• Data collection and report generation
• SOP development and revision
• GMP, ISO, FDA, and OSHA compliance
• OOS, NCMR, CAPA investigation
• Environmental monitoring procedures