Senior Manager, Quality Assurance Management

The Cooper Companies•Trumbull, CT

55d

About The Position

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. 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.

Requirements

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.

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.