Senior Life Science Quality Assurance Specialist

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.

The Life Science Quality Assurance Specialist III is a senior-level employee who reports to the Life Science Quality Manager. Will own Quality Systems working with stakeholders in facilitating meetings, providing data from tracking and trending, leading quality and continuous improvements. Role will have the responsibility to train the organization on the Quality Systems, as well as mentoring Quality Team members. Will help drive change that will remediate the risks to internal and external customers. 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. In this role the candidate will mentor and train new personnel on the Quality System(s). Will partner with stakeholders to improve the quality program and culture.