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CooperCompanies · 1 day ago

Director, Quality Systems

75 Corporate Drive, Trumbull, CT, 06611, US

Full-time

Onsite

Director/Executive

8+ years exp

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. The Director of Quality Systems will partner with senior management to facilitate quality management systems across multiple sites, drive quality improvement activities, and ensure compliance with regulations in the medical device and pharmaceutical sectors.

Medical Device

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

Qualification

ISO 13485FDA CFR 820EU MDRQuality Management SystemsEQMS softwareData analysisLeadershipCommunication skillsProblem-solving skillsTime management

Required

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

Preferred

Advanced degree preferred

Professional affiliations in Quality Management preferred

Benefits

Medical coverage

401(k)

Parental leave

Fertility benefits

Paid time off for vacation

Personal, sick and holidays

Multiple other perks and benefits

Company

CooperCompanies

CooperCompanies (Nasdaq: COO) is a leading global medical device company focused on helping people experience life’s beautiful moments through its two business units, CooperVision and CooperSurgical.

Founded in 1958

San Ramon, California, US

10001+ employees