Quality
Senior Expert Quality Management International (m/f/d)
Address: Else-Kröner-Str. 1, Bad Homburg, 61352, Germany
Job ID: R0252319
Location Type: Hybrid
- Overview
- Job Description
- 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
Senior Expert Quality Management International (m/f/d)
At Fresenius Medical Care, we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision —“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 110,000 employees.
Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth.
Overall aim of the position:
As Senior Expert Quality Management International, you will play a key role in supporting and strengthening Fresenius Medical Care’s international Quality Management System (QMS). You will support the Management System Representative, Head of QMS International, in the development, maintenance and implementation of the international QMS for Medical Devices, pharmaceutical quality requirements and GxP-relevant systems.
The purpose of this position is to ensure regulatory compliance, inspection readiness and effective implementation of the Quality Management System across relevant international business areas. In this role, you will act as an important interface between Corporate Headquarters, global functions, international business areas and QMS related functions.
Your tasks:
- Supporting the implementation, maintenance and continuous improvement of the international Quality Management System
- Providing implementation support to relevant business areas and overseeing implementation status
- Ensuring regulatory compliance and inspection readiness of the Medical Device QMS, pharmaceutical quality systems and GxP-relevant processes
- Supporting management oversight activities related to the quality system
- Preparing, supporting and following up on regulatory authority inspections, certification audits and TÜV audits
- Ensuring required certifications, licenses and authorizations, such as MDSAP, ISO 13485 and GxP, as applicable to the respective business area
- Coordinating strategic initiatives, ensuring execution and implementation
- Providing reports to management about key QMS indicators and other related Q metrics
Your profile:
- At least 10 years of experience in Quality Management Systems or Regulatory Affairs within the healthcare industry, including at least 5 years in the medical device industry or relevant experience in pharma or GxP environments such as GMP or GDP
- Strong knowledge of Medical Device Quality Management, GxP requirements, applicable regulatory requirements and relevant certification standards, including ISO 13485 and MDSAP
- Proven experience in implementing, maintaining or improving QMS or other management systems in a responsible function
- Experience in preparing, hosting, leading and following up on regulatory authority inspections, TÜV audits or certification audits
- Ability to read, understand and interpret regulations and translate them into practical business processes
- Good knowledge of MS Office applications as well as practical experience with ERP systems and workflow solutions
- Very good English skills; additional languages are a plus
- Experience in leading diverse teams in multi-site, international environments
- Strong prioritization skills, accountability and the ability to manage ambiguity in changing business environments
- Willingness to respond quickly in critical situations, such as quality issues or unannounced audits, and to work globally across different time zones
Our offer for you:
There is a lot you can discover at Fresenius Medical Care, regardless in which field you are an expert and how much experience you have - all dedicated to your professional journey.
- Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
- A large number of committed people with a wide range of skills, talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company
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.
Leadership
Communicator
Compassionate
Problem-solver
Motivational
Good Listener
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.
Commpassionate Patient Care
Empathetic
Team Player
Detail Oriented
Efficient
Responsible
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.
Communicator
Compassionate
Detail Oriented
Relationship Expertise
Facilitator
Leadership
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.
Compassionate
Flexible
Independent
Quick-thinking
Patient
Responsible
“I successfully completed the RN program and went on to hold the position of Staff RN, Charge Nurse, and finally Clinical Manager.”
Rosalyn,
Clinical Manager
Clinical Manager
“Every day I walk in I am changing lives for the better and working to inspire my patients.”
Andrew,
Patient Care Technician
Patient Care Technician
“I am a member of an outstanding team that helps patients gain more control, achieve tangible goals, and live better lives.”
Tony,
Outpatient Services RN
Outpatient Services RN
“My goal is to make sure that our patients keep their mobility and quality of life. This goal is really personal for me. My own father always had really bad vasculature in his leg and never had access to the kind of care we offer — eventually he lost blood flow and mobility. Knowing what he went through makes me even more committed to our mission.”
Warren J.
Azura Regional Vice President
Azura Regional Vice President
We've got your back.
We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.
Healthcare
Continuing Education
Paid Time Off
Collaborative Environment
Additional Perks
401(k) Retirement Saving
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