Director of Quality Operations Active Medical Device & Digital Products (mfd)
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Job Location:
Schweinfurt - Germany
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 510 years in senior leadership roles within the medical device pharma or healthcare sector.
- In-depth knowledge of quality and regulatory frameworks (ISOCFR 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.
Required Experience:
Director
Key Skills
- Risk Management
- Negiotiation
- Operational management
- Smartsheets
- Strategic Planning
- Team Management
- Budgeting
- Leadership Experience
- Program Development
- Supervising Experience
- Financial Planning
About Company
Fresenius Medical Care provides healthcare professionals with products and solutions for patients renal failure and CKD. Learn more about our product line.
