Director, Quality Systems na CVI

• 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. 

Knowledge, Skills and Abilities:

• 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.

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:

• 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.

Education:

• 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.

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. Please visit us at www.coopersurgical.com to 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 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 [email protected]