Senior Quality Assurance Manager – Medical Devices

About the role

We are looking for a senior leader to head the Quality function at our Montevideo site, ensuring compliant, high‑quality manufacturing of medical devices and components. The role serves as the Site Management Representative with full responsibility for the Quality Management System (QMS) and regulatory readiness.

Key responsibilities

• Lead and maintain compliance with FDA QSR, ISO 13485, GMP, and all applicable safety and environmental regulations.
• Develop, implement, and continuously improve the QMS in line with company policies and regulatory standards.
• Act as Management Representative, overseeing internal and external audit programs, document control, record management, and product traceability.
• Drive CAPA, risk‑based quality processes, and continuous improvement initiatives across the product lifecycle.
• Partner with Operations, R&D, Regulatory, and Commercial teams to align quality objectives with business goals.
• Lead, coach, and develop a team of quality managers, engineers, and technicians.
• Define quality strategy, KPIs, tactical plans, and manage the departmental budget.

Required profile

• Bachelor’s degree in Engineering, Pharmaceutical Chemistry or a related field.
• 10+ years of experience in technical or quality roles within regulated industries.
• 5+ years of people‑leadership experience.
• Advanced English proficiency.
• Preferred: Master’s degree and prior experience as a Quality Management Representative.

Required skills

• FDA Quality System Regulation (21 CFR Part 820)
• ISO 13485
• Good Manufacturing Practices (GMP)
• Quality Management Systems
• CAPA processes
• Risk‑based quality methodologies

What we offer

• Strategic leadership opportunity in a highly regulated industry.
• Impact on business performance and product quality.
• Development of high‑performing teams in a dynamic manufacturing environment.