/ CAREER WITH A PURPOSE /

Fresenius Medical Care - Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products - that is Fresenius Medical Care.
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(Senior) Expert (m/f/d) IT Quality

Within Fresenius Medical Care, the QREM Department (Quality, Regulatory Affairs & Management Systems) has the key responsibility to ensure that the company maintains and receives its marketing authorizations (e.g. CE-marks or drug registrations). Having identified legal requirements and regulations for the company, QREM works with different departments guiding them and ensuring that regulatory compliance and regulatory prerequisites for medical devices & drugs are met.

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Within Fresenius Medical Care, the QREM Department (Quality, Regulatory Affairs & Management Systems) has the key responsibility to ensure that the company maintains and receives its marketing authorizations (e.g. CE-marks or drug registrations). Having identified legal requirements and regulations for the company, QREM works with different departments guiding them and ensuring that regulatory compliance and regulatory prerequisites for medical devices & drugs are met.

Your assignments

As a (Senior) Expert (m/f/d) IT Quality, you will render support the assurance of regulatory compliance of business processes within a regulated IT environment (in particular GxP, ISO 13485, GAMP 5). The focus here is to ensure compliance with the requirements of the European Medical Device and Pharmaceutical Regulation and the associated requirements governing quality management systems.

Your role entails monitoring and participating in the implementation of state of the art technology in regulated IT environment ( in accordance with EU regulations such as GxP, ISO 13485, GAMP 5). You will act as an interface between the business units Quality Management System (QMS) and IT or IT service providers. Implementation of quality assurance measures in the corresponding business areas (e.g. IT compliance audits) will be part of your task in this position.

While supporting the quality assurance unit in fulfilling relevant documentation requirements, you will draft, verify or evaluate user requirements specifications, functional specifications and validate documentation for regulated computerized systems.

Furthermore, you will render support in the implementation of risk management, of IT QA processes and you will assist in staff trainings focusing on IT quality. Moreover, you will act as an interface to other Fresenius legal entities to harmonize requirements of the Fresenius Group.

Your profile

As a (Senior) Expert (m/f/d) IT Quality, we expect you to have a graduate degree in technical/scientific/ IT/ and or quality management studies or similar educational background with relevant professional expertise in a similar function.

You will bring in your experience in IT Audit, IT Validation or IT System compliance exhibiting knowhow in regulatory IT compliance (EU-GxP) and in the validation of regulated computer-based systems according to EU-GMP Annex 11 and GAMP 5.

Your expertise in the EU regulatory requirements within the pharmaceuticals and medical devices industries (e.g. Directive EU 2001/83/EC, AMG, Regulation EU 2017/745/EU & Quality Management Systems ISO 9001/13485, EU-GDP, EU-GMP as well as GAMP 5) is something you are eager to demonstrate. Cross-organizational assertiveness and strong communication skills round off your profile.

Your intercultural diplomatic competence as well as your professional demeanor will surely come in handy in this expert role.

If you enjoy using your proficient German and English language skills (orally and written) and you have willingness to travel then we look forward to getting your application.

At a glance

Career level:

Professional Experienced

Job category:

Internal Audit / Legal / M&A, IT Department

Working condition:

Permanent contract / Full-time

Business segment:

Fresenius Medical Care

Location:

Bad Homburg / Hessen

Closing date for applications:

none - we look forward to your application

Your contact

  • Fresenius Medical Care Deutschland GmbH
  • Bad Homburg
  • Ref. number: 31059

About Fresenius

Career with a purpose:

Over 270,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.

career.fresenius.com fresenius.com

 

One of Fresenius' strengths:

our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.

More reasons

 

The benefits we offer:

Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.

More benefits

Your contact

  • Fresenius Medical Care Deutschland GmbH
  • Bad Homburg
  • Ref. number: 31059
Career level:

Professional Experienced

Job category:

Internal Audit / Legal / M&A, IT Department

Working condition:

Permanent contract / Full-time

Business segment:

Fresenius Medical Care

Location:

Bad Homburg / Hessen

Closing date for applications:

none - we look forward to your application

About Fresenius

Over 270,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
career.fresenius.com fresenius.com

One of Fresenius' strengths:

our corporate culture for “entrepreneurs in an enterprise” where you can quickly take on responsibility.

More reasons
The benefits we offer:

Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.

More benefits