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CooperCompanies · 21 hours ago

Director, Quality Assurance Management

95 Corporate Drive, Trumbull, CT, 06611, US

Full-time

Onsite

Director/Executive

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. The Director of Quality Assurance Management will serve as the Site Head of QA, managing the QA team and ensuring compliance with relevant regulations while fostering a culture of continuous improvement and quality across the organization.

Medical Device

Responsibilities

Serve as the Site Head of QA and the management representative for the Costa Rica site

Develop and maintain a site QA organizational structure aligned with the global quality strategy

Manage QA oversite of multiple complex value streams

Lead and mentor site QA team, fostering a culture of quality, continuous improvement, and compliance

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 primary quality representative for site leadership and cross-functional teams

Ensure site compliance with 21 CFR 820, ISO 13485, ISO 13408, EU MDR, and other applicable regulations

Lead site readiness and response and serve as the host for regulatory inspections and external audits

Oversee the implementation and maintenance of the Quality Management System (QMS)

Manage CAPA, change control, document control, training, and internal audit programs

Drive continuous improvement initiatives using tools such as Six Sigma, Lean, and root cause analysis

Oversee product release decisions

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

Represent the site and CooperSurgical at any events, conventions, seminars, trainings, etc. held outside of CooperSurgical facilities

Perform other duties as assigned

Qualification

21 CFR 820ISO 13485EU MDRLeadership experienceAseptic processingContamination control strategiesRegulatory audits/inspectionsMicrosoft ExcelMicrosoft WordMicrosoft PowerPointAnalytical skillsSpanish languageEnglish languageInterpersonal skillsProblem-solving skillsTime management skillsCommunication skills

Required

Proven leadership experience managing QA teams and site-level quality operations

In-depth knowledge of 21 CFR 820, ISO 13485, EU MDR, 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 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 analytical, problem-solving, and decision-making skills

Excellent communication and interpersonal skills

Must be proficient in the use of Microsoft Excel, Microsoft Word, Outlook, and PowerPoint

Experience in hosting regulatory audits/inspections is required

Ability to read, understand, and write highly technical material

Proficient in reading, writing, and communicating in both the Spanish and English language

Company

CooperCompanies

CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical.

Founded in 1958