About this role
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 business unit of CooperCompanies (Nasdaq: COO) , we're driven by a unified purpose of helping people 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.
Knowledge, Skills and Abilities:
- Expert knowledge and practical application of 21 CFR 820, QMSR, ISO 13485, ISO 13408, and EU MDR.
- Strong aseptic/sterility assurance background, including contamination control strategy, environmental monitoring programs, and aseptic process simulation/media fill oversight aligned with ISO 13408 and global expectations.
- Demonstrated expertise leading complex deviations/nonconformances, investigations, and CAPA, including robust root cause analysis and effectiveness verification.
- Direct experience serving as a subject matter expert and leading responses for regulatory inspections and external audits (FDA and/or Notified Body), including front-room participation and written response ownership.
- Hands-on experience governing core QMS processes (CAPA, change control, document control, training, internal audits) and driving measurable continuous improvement.
- Strong analytical and communication skills, including the ability to translate data and quality risk into clear recommendations for site and global leadership.
- Fluent English required; Spanish proficiency strongly preferred (or ability and willingness to quickly develop working proficiency).
Work Environment:
- Onsite Production/Clean Room/Warehouse/Office Environment which may require long periods of sitting, standing, or getting up and down throughout the day.
- Occasionally lift to 35 pounds.
Experience:
- 7+ years of progressive quality experience in regulated manufacturing, including medical devices, pharma, and /or biologics.
Education:
- Bachelor’s degree in Life Sciences, Engineering, or a related field (advanced degree a plus).
- Advanced degree or certifications (e.g. CQE, Six Sigma) preferred.