CooperCompanies · 2 months ago
Director, Design Assurance and Risk Management
75 Corporate Drive, Trumbull, CT, 06611, US
Full-time
Onsite
Director/Executive
10+ years expCooperSurgical is a leading fertility and women’s healthcare company dedicated to supporting patients throughout their lifetimes. The Director of Design Assurance and Risk Management is responsible for overseeing compliance in design and development processes while managing global initiatives and ensuring effective risk management systems are in place.
Medical Device
Responsibilities
Partner with Cooper Surgical senior management and site management to facilitate new product development quality activities
Ensure that design and development practices incorporate current global regulatory compliance expectations as required by FDA QSR, ISO 13485, MDR, ISO 14971, etc
Responsible for directing the efforts associated with QA functions related to design quality engineering and design change management
Lead design quality engineering and technical support for product realization and market release
Ensure development projects are resourced and supported through the design process
Assist in establishing robust programs to ensure new products are designed for manufacturability and compliant with all applicable regulations
Manage the process for risk management activities throughout the product lifecycle
Function as the subject matter expert on design, development, and risk management matters
Lead design transfer activities to ensure success of new designs in manufacturing
Function as the quality champion for IT projects impacting design assurance function and/or systems
Design, establish, implement, and maintain a resource plan that fully supports the needs of the business to support growth initiatives
Solicit internal and external feedback with the goal of continuously improving processes or products
Partner with global departments to ensure the seamless integration of quality standards throughout product lifecycle stages
Monitor customer feedback and corrective actions, making improvements to products based on feedback
Lead strategic planning, direction, and goal setting for the department or function
Instill a culture of continuous improvement by developing and implementing strategies that achieve measurable results
Manage a team of direct reports and provide guidance, coaching, evaluation and hiring of quality personnel as needed
Perform other duties as assigned
Qualification
Required
Extensive knowledge of ISO 13485, FDA CFR 820, MDR, ISO 14971
Ability to read, understand, and write highly technical material
Ability to work in a matrixed organization, developing strong relationships with all levels of staff and management partnering across multidisciplinary teams (internal/external)
Excellent 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 conclusion, with the ability to manage and lead without direct authority
Strong organizational, interpersonal, verbal, and written communication skills (clear, concise, effective with a variety of stakeholders)
Strong data analysis, negotiation, and problem-solving skills
10+ years of experience in quality assurance within the medical device, pharmaceutical, or life sciences sectors
5+ years of experience in a leadership role overseeing design assurance and risk management
Expert knowledge of quality system requirements
Experience with MS Word, Excel, Project Management and Analytics software
Experience liaising with multiple international regulatory bodies and managing cross-cultural teams
Bachelor's degree in Science or Engineering field required
Preferred
Continuous improvement experience strongly preferred (6 Sigma, Lean, Green Belt/Black Belt)
Advanced degree preferred
Professional affiliations in Quality Management preferred
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation, personal, sick and holidays
Multiple other perks and benefits
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.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Agostino Ricupati
SVP Finance - Tax and Chief Accounting Officer
June White
Principal Business Partner, Inclusion & Diversity
Recent News
2024-05-04
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2024-05-04
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