CooperSurgical · 2 weeks ago
Senior Manager, Quality Assurance Management
Trumbull, CT
Full-time
Onsite
Senior LevelCooperSurgical is a leading fertility and women’s healthcare company dedicated to improving healthcare moments for women and families. The Senior Manager of Quality Assurance Management will oversee the QA operations at the Trumbull site, ensuring compliance with regulations and fostering a culture of continuous quality improvement.
Health CareMedical DeviceWomen's
Responsibilities
Serve as the Site Head of QA and the management representative for the Trumbull, CT site
Work with senior leadership to develop and maintain a site QA organizational structure aligned with the global quality strategy
Lead strategic planning, direction, and goal setting for site QA team
Instill a culture of continuous quality improvement by developing and implementing strategies that achieve measurable results
Manage, hire, train, evaluate, and provide guidance and coaching to site QA personnel
Serve as the quality representative for site leadership and cross-functional teams
Ensure site compliance with 21 CFR 820, ISO 13485, EU MDR, MDSAP, and other applicable regulations
Lead site readiness and response and serve as the host for regulatory inspections, internal, and external audits
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
Collaborate with manufacturing, engineering, and R&D to resolve quality issues and improve processes
Monitor and report on key quality metrics and trends
Host periodic management review meetings
Participate in other projects as directed by senior and executive leadership
Perform other duties as assigned
Qualification
Required
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
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 organization
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
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation, personal, sick and holidays
Multiple other perks and benefits
Company
CooperSurgical
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.
Founded in 1990
1001-5000 employees
H1B Sponsorship
CooperSurgical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (10)
2023 (10)
2022 (13)
2021 (5)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Lisa Fawcett
Executive Vice President, Strategy & Market Development
Recent News
MarketScreener
2025-08-29
2025-08-27
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