Director of Quality Operations Active Medical Device

Vor 5 Tagen

Schweinfurt, Deutschland Fresenius Medical Care Vollzeit 90.000 € - 120.000 € pro Jahr

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.

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