Director of Quality Operations Active Medical Device

Requirements

• Establish, maintain and continuously improve an effective Quality Management System (QMS) in compliance with ISO 13485, ISO 27001 and global regulatory standards (e.g., FDA, MDR).
• Define and develop Manufacturing Quality Strategy for AMD Network in alignment with global business strategy.
• Provide strategic leadership for Quality Operations across multiple sites, including QA, QC and QMS functions.
• Ensure compliance through internal and external audits, CAPA management and quality reporting.
• Collaborate closely with Manufacturing, R&D and Suppliers to ensure product and process quality.
• Align local systems with corporate GMS standards and certification requirements.
• Lead and develop a diverse, high-performing quality team.
• Exercise decision-making authority in critical quality matters, including production holds when necessary.
• Manage departmental budgets and monitor performance through defined KPIs.

Your Profile

• Degree in Science, Engineering or related field; advanced qualification in Quality Management preferred.
• Minimum of 10-15 years of professional experience in Quality Assurance, with at least 5–10 years in senior leadership roles within the medical device, pharma or healthcare sector.
• In-depth knowledge of quality and regulatory frameworks (ISO 13485, 21 CFR 820, ISO 14971, MDR).
• Strong leadership, communication and presentation skills, especially in executive settings.
• Proactive, solution-oriented mindset with strong change agility.
• Skilled in using quality management tools (SAP, TrackWise, SharePoint, etc.).
• Fluent in English and German (written and spoken).
• Experience with dialysis, ECMO or other Class IIb/III active medical devices preferred.

Benefits

• Strategic leadership role in a global Quality network.
• Direct impact on the quality and safety of life-saving medical devices.
• Opportunity to drive global compliance and certification programs.
• Collaboration with international experts in a cross-functional environment.
• Tailored training and career development opportunities.
• Flexible working models and cross-site collaboration.
• Long-term stability in a growing, regulated industry.