Internal Audit Program Specialist

About CooperSurgical

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. 

Work location: Trumbull, CT or Stafford, TX (on-site)

Scope:

The Internal Audit Program Coordinator will support and maintain the global internal audit program for a medical device organization operating under ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, and EU MDR requirements. This role focuses on planning, coordinating, and executing internal audits across multiple manufacturing sites and functions, both remote and onsite. Responsibilities include scheduling audits with qualified internal staff and external resources, ensuring compliance with regulatory and quality system standards, and performing audits directly as skills develop. This position is designed for an early-career professional seeking growth in auditing and quality systems, with opportunities to expand technical expertise and assume greater audit responsibilities over time.

Job Summary:

The Internal Audit Program Coordinator supports and maintains the global internal audit program for a medical device organization operating under ISO 13485, FDA 21 CFR Part 820/QMSR, MDSAP, and EU MDR requirements. This role is responsible for coordinating internal audits with qualified internal staff and external resources, as well as performing audits directly as experience grows. The Internal Auditor ensures audits are planned, executed, and documented in compliance with regulatory and quality system standards, contributing to continuous improvement and organizational compliance.