Director, Quality Assurance & Regulatory Compliance

About the role

CooperVision is seeking a senior leader to oversee Quality Assurance and Regulatory Compliance for its Puerto Rico manufacturing site. The Director will ensure that contact lens production meets global quality standards, regulatory requirements, and patient‑safety goals.

Key responsibilities

• Lead the QA department to guarantee that manufacturing processes consistently deliver lenses that satisfy CooperVision specifications and external regulations.
• Drive strategic quality initiatives across the site and align them with global quality objectives.
• Manage all regulatory inspections, certification audits, customer audits, and corporate quality assessments, ensuring readiness and timely resolution of findings.
• Oversee product release criteria, including sterility, safety, efficacy, and labeling compliance.
• Develop and monitor QA performance metrics that support global scorecards and business priorities.
• Advise senior operations leaders on QA issues that could impact production or product release.
• Build QA capability through talent management and succession planning.

Required profile

• Proven senior leadership experience in quality assurance and regulatory compliance within a medical‑device or related manufacturing environment.
• Deep knowledge of global quality management systems, medical‑device regulations, and industry standards.
• Strong track record of leading audits, inspections, and continuous‑improvement programs.
• Excellent communication skills to influence cross‑functional leadership.

Required skills

• Quality Management System (QMS) expertise
• Regulatory compliance knowledge for medical devices
• Audit and inspection management
• Performance metric development and analysis