Director, Design Assurance and Risk Management

CooperSurgical is a leading fertility and womens 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 were driven by a unified purpose to enable patients to experience lifes 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 womens 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.

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.

Essential Functions & Accountabilities:

• 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.

Travel:

This position may require 15-25% domestic and/or foreign travel.

Qualifications

Knowledge Skills and Abilities:

• Extensive knowledgeof ISO 13485 FDA CFR 820 MDR ISO 14971.

• Continuous improvement experience strongly preferred (6 Sigma Lean Green Belt/Black Belt)

• 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 siteand 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.

Work Environment:

• Prolonged periods of sitting especially in front of a computer.
• Potential exposure to different manufacturing environments necessitating adherence to varying safety protocols.

Experience:

• 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.

• Expertknowledge 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.

Education:

• Bachelors degree in Science or Engineering field required; Advanced degree preferred.
• Professional affiliations in Quality Management preferred. Required licenses if any must be maintained and periodically renewed as needed.

As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us at learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability please contact us at