Director of Quality, Regulatory Compliance & Assurance

CooperVision; Juana Díaz (PR); On-site; USD 140,000 - 180,000; Full time

Job summary

CooperVision, a global leader in contact lenses, seeks a seasoned Quality Leader for Puerto Rico operations. This onsite role drives QMS compliance, regulatory readiness, and continuous improvement across manufacturing and quality systems.

You will lead a high-performing QA organization, ensure FDA/ISO compliance, and partner with Global Quality to meet patient safety and business objectives. Fluency in English and Spanish is required, with a focus on leadership and strategic quality delivery.

Qualifications

• 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.

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.

Skills

Quality leadership

Regulatory inspections

CAPA & root cause

Bilingual English/Spanish

Project management

Analytical thinking

Education

Bachelor's degree in science/engineering

Tools

Microsoft Office

Job description

CooperVision, a global leader in contact lenses, seeks a seasoned Quality Leader for Puerto Rico operations. This onsite role drives QMS compliance, regulatory readiness, and continuous improvement across manufacturing and quality systems.

You will lead a high-performing QA organization, ensure FDA/ISO compliance, and partner with Global Quality to meet patient safety and business objectives. Fluency in English and Spanish is required, with a focus on leadership and strategic quality delivery.