Director – Quality Assurance & Regulatory Compliance

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.

Essential Functions & Accountabilities:

• Lead the QA department to ensure manufacturing processes produce contact lenses that meet CooperVision’s specifications, customer and external regulatory requirements

• Drive the Strategic Quality plans through leadership and across the manufacturing site.

• Lead and oversee all regulatory inspections, certification audits, customer audits, and corporate quality assessments, ensuring organizational readiness, effective inspection management, and timely resolution of observations and commitments. 

• Responsible for ensuring all contact lenses meet the required release criteria including sterility, safety, efficacy and labeling

• Develop, implement and oversee meaningful QA performance metrics that support both Global Quality and business goals, ensuring alignment with the Global Scorecard and enterprise strategic priorities.

• Advise and guide leadership and Senior Operations Managers on QA-related issues that could affect the production or non-release of products.

• Develop the capability of the QA function and ensure that talent management and succession planning provide for the future needs of the business.

• Serve as the primary Quality leader and escalation point for significant product quality issues impacting products manufactured at the Puerto Rico site, ensuring timely investigation, decision-making, risk assessment, and resolution in partnership with Global Quality.

• Ensure effective escalation management and tools for corrective and preventive activities, including NCR, CAPA, HHE, change control, validations and audits.

• Leads and drives the application of effective problem-solving and root cause analysis methodologies to resolve quality issues, prevent recurrence, and support continuous improvement.

• Heads QA projects to develop functional capability on delivering a QMS that enables the changing needs and technology of PRMO in harmony with CooperVision global objectives.

• Direct the Management Review process and participate as required for the PRMO and regional/global business management reviews within CooperVision.

• Promote management's commitment to the development, implementation, and ongoing effectiveness of the Quality Management System by communicating the importance of meeting customer, statutory, and regulatory requirements throughout the organization.

• Actively participate in the Operational Excellence programs, including their forums and activities, while promoting and supporting the culture of continuous improvement within the organization.

• Establish stretch goals and monitor results and budget, demonstrating financial acumen.

• Lead, coach, and develop a high-performing Quality organization by fostering a culture of accountability, inclusion, innovation, continuous improvement, and regulatory excellence.

• Build organizational capability through talent reviews, succession planning, workforce planning, and leadership development initiatives.

• Establish clear performance expectations, provide ongoing coaching and feedback, and develop future leaders to ensure organizational readiness and business continuity.

• Ensure site compliance with applicable FDA, ISO 13485, MDSAP, MDR, and other global regulatory requirements, maintaining a state of continuous inspection readiness.

• Partner with Regulatory Affairs and Global Quality teams to assess the impact of changing regulations and ensure timely implementation of required actions.

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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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.