Quality Control Engineer I

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

• Supports the execution of qualification and validation activities and ensures adherence to approved protocols and timelines. Assists with protocol preparation, data collection, and report generation for analytical equipment in the QC laboratory.

• Assists in the execution of laboratory testing activities for analytical method development and validation under supervision.

• Maintains laboratory equipment records, including calibration and maintenance schedules, and supports coordination of routine maintenance, re-qualification activities and repairs.

• Participates in troubleshooting activities and performs root cause investigations for laboratory equipment and processes not conforming to specifications.

• Supports the monitoring of equipment alarms by documenting events, notifying appropriate personnel, and assisting in follow-up actions.

• Assists in monitoring and trending laboratory testing data and prepares summaries for review by senior staff.

• Works cross-functionally with QC technicians and other departments to support routine laboratory operations and escalate technical issues as needed.

• Performs preliminary review of laboratory data and documentation to ensure completeness and accuracy prior to formal approval.

• Develops foundational technical knowledge in analytical methods, equipment operation, and laboratory processes.

• Supports audit readiness activities and ensures compliance with internal procedures and applicable regulatory requirements (GMP, ISO, FDA).

• Assists in the transfer and implementation of quality control methods and equipment into laboratory and production environments.

• Supports the preparation, revision, and implementation of SOPs within the quality management system.

• Performs laboratory investigations, including OOS, NCMR, CAPA, out-of-tolerance results, and environmental monitoring excursions, ensuring accurate documentation of findings.

• Complies with GMP, ISO, FDA, OSHA, and company quality and safety standards in all assigned activities.

• Performs other duties as assigned by management.
  

Knowledge, Skills and Abilities:

• Basic understanding of analytical techniques and laboratory equipment.
• Familiarity with GMP, GLP, and quality system requirements.
• Strong attention to detail and documentation practices.
• Ability to work in a team environment and communicate effectively.
• Proficiency in Microsoft Office tools.
• Basic problem-solving and analytical skills.
• English language proficiency at a B1 level or higher

Experience:

• 1–2 years of experience in a quality control laboratory or regulated environment preferred.

Education:

• Bachelor’s degree in Chemistry, Microbiology, Biomedical Engineering, Chemical Engineering, Biotechnology Engineering, Industrial Bioprocess Engineering or related field.