Quality Systems Lead: Change, CAPA & Compliance

CooperVision; Juana Díaz (PR); On-site; USD 90,000 - 110,000; Full time

Job summary

CooperVision is seeking a Quality Improvement and Design Leadership professional in Juana Díaz, Puerto Rico. The role directs the Quality Improvement (Design) team and ensures implementation of Quality Systems Improvement strategies in compliance with applicable laws.

The incumbent manages recruitment, performance, and cross-functional collaboration, supporting ECO processes and acting as a focal point for R&D SME’s. Strong leadership and regulatory knowledge are essential.

Qualifications

• Bachelor’s degree required in Sciences (Chemistry / Biology / Engineering).
• Proven knowledge of quality systems regulations in medical device/pharma industries.
• Strong project management and leadership abilities required.
• Experience with metrology equipment and statistics is a plus.

Responsibilities

• Quality Improvement Projects and Calibration / Preventive Maintenance administration.
• Monitor Quality Systems Performance and establish goals.
• Review SOP Changes, IT requirements and CAL/PM documentation.
• Assist in ECO process coordination and RA/QA interface.

Skills

Quality Systems

Project management

Change Control

Risk Management

Metrology

Clinical studies

Statistics

Leadership

Communication

Bilingual

Education

Bachelor’s degree in Sciences

Tools

Microsoft Office

Quality Documentation Systems

Job description

CooperVision is seeking a Quality Improvement and Design Leadership professional in Juana Díaz, Puerto Rico. The role directs the Quality Improvement (Design) team and ensures implementation of Quality Systems Improvement strategies in compliance with applicable laws.

The incumbent manages recruitment, performance, and cross-functional collaboration, supporting ECO processes and acting as a focal point for R&D SME’s. Strong leadership and regulatory knowledge are essential.