Senior Life Science Quality Assurance Specialist

Cooper Surgical 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 Cooper Companies, 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

Work location:

Livingston, NJ (on-site)

The Life Science Quality Assurance Specialist III is a senior‑level employee who reports to the Life Science Quality Manager. The role owns Quality System(s), facilitates meetings, provides data from tracking and trending, leads quality and continuous improvements, trains the organization on the Quality System(s), mentors Quality Team members, and drives change that remediates risks to internal and external customers.

The Life Science Quality Assurance Specialist III is primarily responsible for establishing, developing, implementing, maintaining and improving Quality System processes and programs to include:
Quality Event Reporting (Deviations, Nonconformance, Change Management, CAPA, Complaint), Document Control Program, Supplier Qualification, Validations, and Product Transfer. The candidate will mentor and train new personnel on the Quality System(s) and partner with stakeholders to improve the quality program and culture within the organization. Strong written and verbal communication skills, cross‑functional collaboration, positive influence, high integrity, and a continuous improvement mindset are required.

• Maintain a culture of quality awareness, teamwork, and cooperation with Quality customers.
• Provide Quality oversight, support and engagement as needed by Operations.
• Owner of Quality Management System Processes such as:
  • Document Control Program: review, approval, and maintenance of company SOPs via an electronic Document Quality Management System.
  • Change Management Program: review, approve, and track changes to approved procedures, validated software and processes, and qualified equipment; review task completion.
  • Deviations and Nonconformances: review, approve, and monitor events and deviations; handle complaints and investigations.
  • Track and facilitate investigations in cross‑functional team discussions to support closing of Quality Events, Change Controls and CAPA.
  • Supply/Vendor Management: supplier qualification, reassessment activities, quality agreements, quality score cards; oversee process maintenance and approval.
  • Audit Program: aid in tracking and trending of internal and external findings; investigate and implement corrective/preventive measures.
  • Validations: review and approve equipment, systems validation/qualification, and any design transfer to operations.
  • Quality Metrics: perform trending analysis and reporting of quality indicators; identify risks and process improvements for operations.
  • Review charts and medical records for completeness of all required testing and documents for various processes.
• Facilitate meetings, provide system visibility, communicate status, and facilitate closure of aging items.
• Gather performance metrics and coordinate Management review inputs from various contributing departments.
• Track, trend, and report Quality System metrics to ensure continuous quality improvements while communicating critical compliance and quality risks.
• Work cooperatively in a team environment to maintain cross‑functional and cross‑site process and procedural consistency for quality systems records.
• Create and implement a training program for the QMS processes to educate Quality Assurance customers.
• Perform other Quality Assurance duties as required.

• Understands and…