Director, Design Assurance and Risk Management

The Cooper Companies•Trumbull, CT

51d

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. The Director of Design Assurance and Risk Management is responsible for overseeing the compliance of the design and development process and risk management process for Cooper Surgical. The Director manages and oversees global initiatives as they impact the design and development activities, and is responsible for the design, development, implementation, and maintenance of a compliant and effective risk management system. This includes partnering with the R&D organization to ensure processes are compliant, dynamic, and agile to meet the demands of the business. This role is also responsible for identifying and securing needed resources to ensure effectiveness and successfully managing a team.

Requirements

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

Nice To Haves

Continuous improvement experience strongly preferred (6 Sigma, Lean, Green Belt/Black Belt)
Advanced degree preferred.
Professional affiliations in Quality Management preferred.

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.