Director, Design Assurance and Risk Management
CooperSurgical2 days ago
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OnsiteFull-timeDirector
Summary
CooperSurgical is seeking a Director, Design Assurance and Risk Management to join their team in Trumbull, CT. The role involves overseeing compliance in design and development processes and managing risk management systems for medical devices.
About the Role
As the Director of Design Assurance and Risk Management, you will be responsible for ensuring that design and development practices meet global regulatory compliance standards. You will lead quality engineering efforts, manage risk throughout the product lifecycle, and collaborate with R&D to support new product development. This role includes managing a team, establishing resource plans, and fostering a culture of continuous improvement.
About You
Required:
- 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.
- Extensive knowledge of ISO 13485, FDA CFR 820, MDR, ISO 14971.
Preferred:
- Continuous improvement experience (6 Sigma, Lean, Green Belt/Black Belt).
- Advanced degree in Science or Engineering field.
- Professional affiliations in Quality Management.
Benefits
- Outstanding total compensation plan including medical coverage.
- 401(k) with company match.
- Parental leave and fertility benefits.
- Paid time off for vacation, personal, sick, and holidays.
CooperSurgical
CooperSurgical is driven to advance the care of women, babies, and families around the world. We believe in empowering individuals and healthcare professionals in making health and life choices. We are trusted by clinicians worldwide for products, technologies, and services that support a wide range of reproductive solutions, from contraception to fertility and preventative and therapeutic gynecological care.
Trumbull, CT