CAPA Expert (m/f/d)
CAPA Expert (m/f/d)
- Art der Beschäftigung: Vollzeit
- 61.000 € – 80.000 € (von XING geschätzt)
- Vor Ort
- Zu den Ersten gehören
CAPA Expert (m/f/d)
Über diesen Job
Quality
CAPA Expert (m/f/d)
Address: Hafenstraße 9, Schweinfurt, 97424, Germany
Job ID: R0225454
- Success Profile
- Rewards
- Connect
As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.
Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.
Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.
Inpatient RNs at Fresenius Medical Care perform dialysis treatments on an acute patient population in a hospital setting, including ICU, ER, Rehab, and Med/Surg units. What makes this role truly unique is the level of autonomy you’ll enjoy. Inpatient nurses are specifically accountable for administering and assessing each patient’s treatment plan. And because dialysis is a critical treatment for many hospital procedures and health conditions, you’ll have the opportunity to work with a wide variety of patients. Ideal candidates possess leadership skills and independence needed to make quick decisions in a fast-paced environment. Must be capable of educating patients and providing exceptional customer service to our partners. Six months to one year of dialysis experience or some form of critical care nursing experience are also required.
Job Description
Requirements
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.
Qualifications & Competencies
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.
Success Profile
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
