Director, Design Assurance and Risk Management

Director Of Design Assurance And Risk Management

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.

Responsibilities

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 knowledge of ISO 13485, FDA CFR 820, MDR, ISO 14971.

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

Work Environment :

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.

Experience liaising with multiple international regulatory bodies and managing cross-cultural teams.

Education :

As an employee of CooperSurgical, you'll 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.

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 place. 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 talent.acquisition@coopersurgical.com.