d) at Fresenius Medical Care

Schweinfurt, Bavaria, Germany

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

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

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

Skills

ISO 13485

ISO 27001

FDA

MDR

21 CFR 820

ISO 14971

Quality Management System

CAPA

SAP

TrackWise

SharePoint

Medical Devices

Fresenius Medical Care

Provides dialysis and renal healthcare services

About Fresenius Medical Care

Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.

Waltham, MassachusettsHeadquarters

1996Year Founded

$39.1MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

11-50Employees

Benefits

Professional Development Budget

Conference Attendance Budget

Flexible Work Hours

Risks

Increased competition from telehealth solutions like Philips' eCareManager 4.1.

Rising mental health challenges may impact FMCNA's employee productivity.

Virtual reality education may face adoption and accessibility challenges in rural areas.

Differentiation

FMCNA is the world's largest fully integrated renal company.

FMCNA offers a comprehensive line of dialysis equipment and renal pharmaceuticals.

FMCNA provides coordinated healthcare services at pivotal care points for chronic conditions.

Upsides

Telehealth market growth supports FMCNA's remote patient monitoring services.

Home dialysis market expansion aligns with FMCNA's patient-centric care approach.

AI integration enhances FMCNA's predictive analytics and personalized medicine capabilities.

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