Senior Manager, Quality Assurance Management

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

The Senior Manager, Quality Assurance, under the direction of the Director, Quality Assurance, is responsible for oversite of the Quality Assurance (QA) activities at the CooperSurgical Costa Rica site for the Media Value Stream (MEVS). The Senior Manager, Quality Assurance will ensure all media products are manufactured in accordance with appropriate Federal, State, and Local regulations.The Senior Manager, Quality Assurance, is responsible for leading and managing all MEVS QA activities at the manufacturing site to ensure compliance with applicable regulatory requirements (including but not limited to 21 CFR 820, ISO 13485, ISO 13408, EU MDR, MDSAP), company policies and industry standards. This role is critical in maintaining product quality, patient safety, continuous improvement and regulatory compliance for the MEVS.

• Proven leadership experience managing QA teams and site-level quality operations.
• In-depth knowledge of 21 CFR 820, ISO 13485, EU MDR, MDSAP, and other global standards.
• In-depth knowledge of ISO 13408, aseptic processing, and contamination control strategies.
• Ability to work in a matrixed organization, developing strong relationships with all levels of staff and management, partnering across multidisciplinary teams (internal/external).
• Strong situational analysis and judgement, able to provide guidance and counsel to site and staff throughout the MEVS.
• Strong time management skills as an individual contributor and as a leader, able to drive individual/team projects to scheduled completion on time.
• Excellent team building and leadership skills, able to motivate team members to drive projects to successful completion, with the ability to manage and lead without direct daily input from senior leadership.
• Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders).
• Strong data analysis, negotiation, and problem-solving skills.
• Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint.
• Experience in hosting regulatory audits/inspections is required.
• Fluent in Spanish. Ability to communicate well in English, both verbally and written.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at

• Provide QA oversight for the MEVS manufacturing processes, including operations, formulation, packaging, and finished good release.
• Oversee, and as needed, participate in day-to-day QA activities including DHR review and approval, NCMR, CAPA, document control, product release, and ECN processes for the MEVS.
• Write, review, and approve Standard Operating Procedures (SOPs) for the MEVS.
• Maintain a working knowledge of aseptic processing concepts and implement requirements defined in a contamination control strategy.
• Instill a culture of continuous quality improvement by developing and implementing strategies that achieve measurable results for the MEVS.
• Ensure the MEVS is compliant with regulatory requirements including but not limited to 21 CFR 820, ISO 13485, ISO 13408, EU MDR, and MDSAP.
• Assist the Director, Quality Assurance during internal and external audits and regulatory inspections, serve as subject matter expert for the MEVS, and as needed, serve as the host for audits and inspections.
• Manage, hire, train, evaluate, and provide guidance and coaching to the MEVS QA personnel.
• Collaborate with manufacturing, engineering, and R&D to resolve quality issues and improve processes.
• Monitor and report on key quality metrics and trends for the MEVS.
• Assist Director, Quality Assurance with and occasionally host periodic management review meetings.
• Participate in other projects as directed by senior and executive leadership.