Senior Life Science Quality Assurance Specialist

About Cooper Surgical

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 are 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

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) and works with stakeholders to facilitate meetings, provide data from tracking and trending, and lead quality and continuous improvements. The Specialist III trains the organization on the Quality System(s) and mentors Quality Team members, helping to drive changes that remediate 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 enhance the quality program and quality culture within the organization. Strong written and verbal communication skills are required to foster cross‑functional collaboration and partnerships, lead by positive influence, maintain a high level of integrity, and possess a strong continuous improvement mindset.