Quality

Head of Design Quality Assurance (f/m/d)

Address:

  • Else-Kröner-Str. 1, Bad Homburg, HE 61352, Germany
  • Hafenstraße 9, Schweinfurt, BY 97424, Germany

Job ID: R0207063

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  • 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.

A female nurse examining her patient

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.

A female nurse examining her patient

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.

A female nurse examining her patient

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.

A female nurse examining her patient

Job Description

In your role as Head of Design Quality Assurance (f/m/d) you will be responsible for disciplinary and functional leadership of the Design Quality Assurance (DQA) group within the SQR – In Center Product Quality & CE Supplier Quality – Design Quality Department.

The Head of Design Quality Assurance (DQA) is responsible for the global leadership and coordination of all Design Quality Assurance activities across the entire product portfolio of In Center—including active, nonactive, and digital medical, digital non-medical devices. This role ensures consistent and compliant execution of design control processes for all development and change projects, supporting regulatory readiness, product safety, and quality by design.

The role combines disciplinary leadership, functional strategy, and hands-on expert guidance, overseeing a globally distributed team across the US, Mexico, Europe, and China. The position acts as a critical interface between development, regulatory, manufacturing, and quality functions, ensuring a harmonized and effective approach to design assurance on a global scale.

Your tasks

  • Provide global disciplinary and functional leadership to the DQA team, covering all product types (active, nonactive, digital) and all regions (US, Mexico, Europe, China)
  • Define and implement the DQA strategy and operating model to ensure consistent execution across geographies and product categories
  • Drive team development, including resource planning, capability building, competency mapping, and succession planning
  • Ensure effective task distribution, resource alignment, and performance delivery across the global team
  • Promote a culture of continuous improvement, lean process thinking, and operational excellence
  • Represent the DQA function in global and local leadership meetings, quality committees, and cross-functional governance bodies
  • Actively contribute to the Design Quality leadership team, collaborating on global strategy, process evolution, and functional alignment
  • Lead the global design quality assurance strategy, ensuring integration across product lines, technologies, and regions
  • Harmonize design quality processes across the organization, establishing a global framework for compliant and efficient design control
  • Serve as a key contributor to regulatory readiness, innovation enablement, and the overall design quality maturity of the Business Unit
  • Coordinate and ensure the implementation of design control activities across all product development and design change projects
  • Oversee compliance with applicable regulations (e.g., FDA 21 CFR 820, EU MDR, ISO 13485, ISO 14971, IEC 62304) and internal design control SOPs
  • Establish and maintain robust design quality processes and tools, including design reviews, phase gates, and documentation systems
  • Monitor and ensure global consistency and high performance of design assurance execution, with clear ownership of deliverables in terms of quality, time, and cost
  • Align with manufacturing and supplier quality teams to ensure smooth design transfer and product realization

Your profile

  • Successfully completed bachelor’s or master’s degree in engineering or a similar technical field, such as medical technology or natural sciences
  • Experience of minimum 5 years in research and development, regulatory affairs or quality management for medical devices or pharmaceuticals
  • Advanced knowledge of medical device regulations (FDA 21 CFR 820, NMPA regulation, EU MDR 745/2017, MDSAP etc.)
  • Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250, etc.)
  • Knowledge of internal and external processes and structures and of the corporate quality management requirements
  • Solid knowledge of CAPA methodology
  • Knowledge of Medical Device field and application
  • High engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work cross functional with all levels of employees
  • Good and professional relationship to and communication with international colleagues and superiors
  • Fluent in English and German, both in written and spoken

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.

Success profile proportion

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.

Success profile proportion

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.

Success profile proportion

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.

Success profile proportion
“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
“Every day I walk in I am changing lives for the better and working to inspire my patients.”
Andrew,
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
“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

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.

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