Director superior de garantía de calidad

About the role

We are looking for a senior Quality Assurance leader to head the site Quality function for a medical‑device manufacturing operation in Montevideo. The role serves as the Site Management Representative, responsible for establishing, implementing and continuously improving the Quality Management System (QMS) in line with FDA QSR, ISO 13485 and local regulations.

Key responsibilities

• Lead compliance with all applicable quality, regulatory, safety and environmental requirements (QMS, EMS, FDA, internal policies).
• Develop, implement and continuously improve the QMS aligned with FDA QSR and ISO 13485.
• Act as Management Representative, ensuring regulatory readiness and effective execution.
• Establish and lead internal and external audit programs.
• Oversee document control, record management and product traceability systems.
• Lead quality activities across the product lifecycle, including design transfer and post‑market surveillance.
• Drive CAPA, continuous‑improvement and risk‑based quality initiatives to improve efficiency and reduce cost.
• Partner with Operations, R&D, Regulatory and Commercial teams to support business objectives.
• Lead, coach and develop quality managers, engineers and technicians.
• Define and manage quality strategy, KPIs, tactical plans and departmental budget.

Required profile

• Bachelor’s degree in Engineering, Pharmaceutical Chemistry or a related field (Master’s preferred).
• 10+ years of experience in technical or quality roles within regulated industries.
• 5+ years of people‑leadership experience.
• Strong knowledge of FDA QSR, ISO 13485, GMP and quality systems.
• Advanced English proficiency.
• Proactive mindset, autonomy, sense of urgency and strong problem‑solving capabilities.

Required skills

• FDA QSR
• ISO 13485
• GMP
• CAPA management
• Risk‑based quality processes
• Audit program management
• Document control
• Product traceability
• Design transfer
• Post‑market surveillance

What we offer

• Strategic leadership of quality in a highly regulated medical‑device environment.
• Opportunity to make a tangible impact on business performance.
• Development of high‑performing teams in a dynamic manufacturing setting.
• Compliance with Uruguayan labor regulations ensuring equal opportunity.