Director, Quality Assurance & Regulatory Compliance

Director, Quality Assurance & Regulatory Compliance

Job Description

At CooperVision, a business unit of CooperCompanies (Nasdaq: COO), we’re driven by a unified purpose of helping people experience life’s beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges – including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at www.coopervision.com This position requires full-time onsite work (5 days per week) in Juana Diaz, P.R.

Responsibilities

Job Summary

This role is responsible for ensuring Puerto Rico Manufacturing Operations produces and releases contact lenses in compliance with the Global CooperVision Quality Management System, applicable medical device regulations, industry standards, and market-specific requirements.

This role serves as the designated Quality Management Representative for the Puerto Rico Manufacturing Operations and is accountable for the effectiveness, compliance, and continuous improvement of the site Quality Management System. The position is a critical member of both the Global Quality Assurance Operations and Puerto Rico Manufacturing Operations leadership teams, providing strategic quality leadership and regulatory oversight to support business objectives and patient safety.

This role is responsible for ensuring Puerto Rico Manufacturing Operations produces and releases contact lenses in accordance with the Global CooperVision Quality Management System, medical device standards, and applicable regulations for all markets where CooperVision products are sold.

Quality System Responsibilities

Lead and maintain the site Quality Management System (QMS), ensuring compliance with applicable regulatory requirements, industry standards, and company policies. Provide Quality oversight for manufacturing and quality system processes, including product release, nonconformance management, CAPA, change control, validation, and risk management activities. Ensure continuous inspection and audit readiness, representing the site during regulatory inspections, customer audits, and corporate assessments, and driving effective resolution of quality issues. Establish a culture of quality and continuous improvement by monitoring quality performance, developing organizational capability, and communicating quality risk and trends to site and executive leadership.

Qualifications

Knowledge, Skills, and Abilities:

• Demonstrated knowledge and application experience of ISO13485, FDA Quality Management System Regulation (21 CFR Part 820) and related regulations, as well as knowledge in all major manufacturing processes and support systems.
• Extensive experience in management and ownership of complex problem resolution, including CAPA, 3rd party inspections, including Notified Body and FDA responses to inspection findings and deficiencies.
• Demonstrated excellent communication skills (oral and written) with all levels of management in both English and Spanish.
• Computer literate with a working knowledge of software programs such as Microsoft Office
• Excellent organizational skills; able to handle, organize, and follow up on multiple priorities.
• Attracts and retains high-caliber talent.
• Builds an inclusive, engaged culture that values diverse backgrounds and perspectives.
• Model high integrity and live the organizational values.
• Proven capability to develop high-performing teams and maintain a culture of Quality and Continuous Improvement.
• Needs to have high analytical capacity and a level of professionalism and judgment to resolve problems.
• Must be a team player. Must be able to work under pressure.

Experience

• 10+ years of progressive Quality leadership experience within a regulated industry.
• Minimum 5 years leading managers and/or multiple Quality functions.
• Experience serving as Management Representative or equivalent quality leadership role during regulatory inspections.

Education

• Bachelor’s degree in sciences, engineering, or related field.

• 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.

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• About Us

• CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.

• At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and an employ