Director of Quality Operations Active Medical Device & Digital Products (m/f/d)
Join to apply for the Director of Quality Operations Active Medical Device & Digital Products (m/f/d) role at Fresenius Medical Care
Responsibilities
* 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.
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.
Seniority Level
Director
Employment Type
Full‑time
Job Function
Quality Assurance, Manufacturing, and Engineering
Industries
Hospitals and Health Care
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