Director of Quality Operations Active Medical Device & Digital Products (m/f/d)
Posted: 10/15/2025, 11:24:12 PM
Location(s): Bavaria, Germany
Experience Level(s): Expert or higher ⋅ Senior
Field(s): Operations & Logistics
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.