Quality Management Supervisor – Complaints & QA Systems

About the role

The role is responsible for overseeing the Complaints and Quality Assurance systems within a global medical technology company. The supervisor ensures compliance with all relevant quality management, regulatory and internal policies while leading a dedicated team.

Key responsibilities

• Develop, implement and maintain a robust Quality Management System (QMS).
• Lead and develop the team, enhancing business acumen and functional skills.
• Identify complex quality issues and drive timely resolution.
• Plan, execute and follow‑up internal and external audits (pre‑assessment, surveillance, certification).
• Oversee the CAPA process, including investigation, root‑cause analysis and verification of actions.
• Manage document control for all quality‑related records.
• Provide guidance and training on quality compliance to all departments.
• Collaborate with R&D, manufacturing and supply‑chain to embed quality‑by‑design throughout the product lifecycle.
• Prepare and present quality performance metrics and compliance reports to senior management.
• Support regulatory submissions and interactions with external regulatory bodies.

Required profile

• Bachelor’s degree in engineering, life sciences or a related technical field (Master’s preferred).
• Extensive knowledge of ISO 13485, FDA 21 CFR Part 820 and EU MDR (2017/745).
• Proven experience managing QMS, CAPA, document control and audit processes.
• Certified Lead Auditor (ISO 13485) strongly preferred.
• Strong analytical, problem‑solving and decision‑making abilities.
• Excellent written and verbal communication in English and Spanish.
• Ability to work independently and collaboratively in a fast‑paced environment.
• Leadership and interpersonal skills to influence cross‑functional teams.

Required skills

• ISO 13485 implementation and auditing.
• FDA 21 CFR Part 820 compliance.
• EU MDR (2017/745) requirements.
• Quality Management System (QMS) development.
• CAPA (Corrective and Preventive Action) management.
• Document control procedures.
• Audit planning and execution.
• Quality management software and tools.

What we offer

• A purpose‑driven environment focused on advancing global health.
• Opportunities to develop expertise in medical device quality and regulatory affairs.