Quality Systems Lead – QA, CAPA & Compliance

Regulatory Jobs; Town of Victor (NY); On-site; USD 58,000 - 78,000; Full time

Job summary

CooperVision, a global leader in contact lenses, seeks a Quality Management System Specialist to oversee QA activities, document control, and change management. The role interacts with global and local teams in Victor, NY, ensuring compliance with GMP and ISO guidelines while supporting continuous improvement initiatives.

The position requires strong QA experience, audit proficiency, and collaboration across departments to maintain robust QMS processes and regulatory compliance.

Qualifications

• Bachelor’s degree in a related field is required.
• 2–3 years of QA experience required.
• Medical Device industry experience preferred.
• Lead auditor experience preferred.

Responsibilities

• Lead QA activities with local (Rochester) and global departments.
• Serve as QA analyst for quality records, problem reports, change orders.
• Support Document Control in Packaging and Labeling QMS data and change control.
• Oversee cross-functional teams contributing to related processes.
• Act as site lead for problem reports and CAPA/NCR handling.
• Perform internal audits at Rochester facilities and other sites.
• Review and revise SOPs/Work Instructions with process owners.

Skills

Quality Assurance

Attention to detail

Cross-functional collaboration

Auditing

Education

Bachelor’s degree in related field

Tools

eQMS

Excel

Microsoft Office

Job description

CooperVision, a global leader in contact lenses, seeks a Quality Management System Specialist to oversee QA activities, document control, and change management. The role interacts with global and local teams in Victor, NY, ensuring compliance with GMP and ISO guidelines while supporting continuous improvement initiatives.

The position requires strong QA experience, audit proficiency, and collaboration across departments to maintain robust QMS processes and regulatory compliance.