Director of Quality Operations Active Medical Device & Digital Products (m/f/d)
Posted:
Friday, 17 October 2025
Valid Thru:
Sunday, 16 November 2025
Index Requested on:
10/17/2025 02:12:03
Indexed on:
10/17/2025 02:12:03
Location:
Schweinfurt, BY, , DE
Industry:
Advertising and Public Relations
Occupational Category:
51-1011.00 - Production
Type of Employment: FULL_TIME
Fresenius Medical Care Holdings, Inc. is hiring!
Description:
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.
Responsibilities:
Please review the job description.
Educational requirements:
Desired Skills:
Please see the job description for required or recommended skills.
Benefits:
Please see the job description for benefits.
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