Director, Quality Systems

The Cooper Companies•Trumbull, CT

36d

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. Partner with Cooper Surgical and Cooper Companies senior management to facilitate the QMS across multiple sites and disciplines. Partner with cross functional team members to drive quality improvement activities and lean principles within the organization. Formulate a strategy on electronic QMS implementation and driving implementation activities collaboratively with cross functional partners. Serve as the expert on quality management systems and compliance across multiple medical device and pharmaceutical disciplines, and ensure sites are supported through implementation and effectiveness activities. Develop and establish Key Performance Indicators (KPIs) for, and act as an owner of Business Quality Management Review (QMR). Lead and oversee change management, CAPA, QMR, internal audit, and training functions for the organization. Function as the subject matter expert on change control, internal audits, and CAPA during external audits and inspections by regulatory authorities. Drive continuous improvement and LEAN activities with the sites to improve efficiency in execution of the QMS. Function as the quality champion for IT projects impacting QMS function and/or systems. Ensure each site has an effective training program and maintains compliance with regulations. Design, establish, implement, and maintain a resource plan that fully supports the needs of the business to maintain a compliant and efficient QMS. 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 10-20% domestic and/or foreign travel.

Requirements

10+ years in the medical device, biotechnology, or pharmaceutical industries with in-depth knowledge of ISO 13485, FDA CFR 820, EU MDR, 21CFR Part11, MDSAP and emerging standards and regulations.
Ability to learn and become proficient in multiple computer-based applications and programs.
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.
8+ years of experience in quality assurance within the medical device, pharmaceutical, or life sciences sectors
5+ years of experience in a leadership role with responsibility for the quality management system.
Expert knowledge of quality system requirements
Experience with eQMS software, MS Word, Excel, Project Management and Analytics software
Experience liaising with multiple international regulatory bodies and managing cross-cultural teams.
Bachelor's degree in Health 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.

Responsibilities

Partner with Cooper Surgical and Cooper Companies senior management to facilitate the QMS across multiple sites and disciplines.
Partner with cross functional team members to drive quality improvement activities and lean principles within the organization.
Formulate a strategy on electronic QMS implementation and driving implementation activities collaboratively with cross functional partners.
Serve as the expert on quality management systems and compliance across multiple medical device and pharmaceutical disciplines, and ensure sites are supported through implementation and effectiveness activities.
Develop and establish Key Performance Indicators (KPIs) for, and act as an owner of Business Quality Management Review (QMR).
Lead and oversee change management, CAPA, QMR, internal audit, and training functions for the organization.
Function as the subject matter expert on change control, internal audits, and CAPA during external audits and inspections by regulatory authorities.
Drive continuous improvement and LEAN activities with the sites to improve efficiency in execution of the QMS.
Function as the quality champion for IT projects impacting QMS function and/or systems.
Ensure each site has an effective training program and maintains compliance with regulations.
Design, establish, implement, and maintain a resource plan that fully supports the needs of the business to maintain a compliant and efficient QMS.
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.