d) at Fresenius Medical Care

Sankt Wendel, Saarland, Germany

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

MedTech, Medical DevicesIndustries

Requirements

Bachelor’s degree in Life Sciences, Engineering, Quality Management, or a related technical field
Minimum 3 years of CAPA management experience in the MedTech industry in an international environment
Strong knowledge of ISO 13485, 21 CFR Part 820.100, EU MDR and GDP requirements
Proven analytical and problem-solving abilities, including experience with structured RCA methodologies
Demonstrated success in cross-functional collaboration and influencing stakeholders
Strong organizational, communication, and project management skills with high attention to detail
Fluent in German and English
Willingness to travel when required

Responsibilities

Lead and manage CAPA investigations, ensuring compliance, effectiveness, and timely execution
Apply structured problem-solving methods to identify root causes and define corrective and preventive actions
Act as CAPA Lead for assigned cases and collaborate cross-functionally with Quality Systems and operational teams
Perform Quality Approver activities for CAPAs and NCs in alignment with regulatory and internal requirements
Drive CAPA/NC reporting, data analysis, and trend evaluations, presenting outcomes to the CAPA Review Board and management
Support audits, inspections, and process improvements, including implementation of new CAPA tools and methods
Provide training, mentorship, and guidance on CAPA and NC processes across multiple sites

Skills

Key technologies and capabilities for this role

CAPARoot Cause AnalysisISO 1348521 CFR Part 820EU MDRGDPQuality ManagementProblem SolvingData AnalysisProject ManagementCross-functional Collaboration

Questions & Answers

Common questions about this position

What qualifications are required for the CAPA Expert role?

A Bachelor’s degree in Life Sciences, Engineering, Quality Management, or a related technical field is required, along with a minimum of 3 years of CAPA management experience in the MedTech industry in an international environment.

What key skills are needed for this position?

Candidates need strong knowledge of ISO 13485, 21 CFR Part 820.100, EU MDR and GDP requirements, proven analytical and problem-solving abilities with structured RCA methodologies, and strong organizational, communication, and project management skills.

Is remote work an option for this role?

This information is not specified in the job description.

What is the salary or compensation for the CAPA Expert position?

This information is not specified in the job description.

What makes a strong candidate for this CAPA Expert role?

Strong candidates will have demonstrated success in cross-functional collaboration, influencing stakeholders, fluency in German and English, and experience supporting audits and providing training across multiple sites.

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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