Job offers

The sister companies Medipan GmbH and GA Generic Assays GmbH are leading providers of laboratory diagnostics and automation in the field of immune diseases. We develop, manufacture, and distribute a wide range of immunoassays and laboratory devices for research and routine diagnostics worldwide.

Both companies have been successfully established in the market for over 30 years. Our global customers include clinics, laboratories, and universities.

To strengthen our quality management team, we are looking for a:

Quality Management Representative (m/f/d)

for our location in Blankenfelde-Mahlow / OT Dahlewitz.

Your New Responsibilities

• • Implementation of the requirements of Regulation (EU) 2017/746 (IVDR)
• • Acquiring knowledge of IVDR guidelines with a focus on in-house in-vitro diagnostics (IVD
• • Assisting in the implementation of IVDR requirements for the manufacturing and use of
•    in-house IVD (methods/devices/software)
• • Supporting departments in evaluating existing validation data and developing strategies to
•   demonstrate the clinical performance of in-house IVD
• • Participating in central quality management according to DIN EN ISO 13485
• • Assisting departments with structured documentation of performance evaluations
• • Conducting and supporting internal and external audits

Your Profile

• • Completed commercial or technical training as a BTA, CTA, CBTA, or a comparable
•   qualification, along with relevant QM certification
• • Qualification as an internal and/or external auditor
• • Several years of professional experience in a similar position
• • Knowledge of DIN EN ISO 13485 and DIN EN ISO 9001
• • Basic knowledge of regulations for in-vitro diagnostics (IVDR)
• • Excellent German and English skills, both written and spoken
• • Team player with enthusiasm for the role
• • Laboratory experience is an advantage

What You Can Expect

• •  A globally active employer with exciting challenges
• •  A permanent position and a secure future
• •  Work in an innovative, growing, and family-owned company with over 30 years of success
• •  Diverse tasks with a high level of responsibility
• •  Full-time position (40 hours/week)
• •  No shift or weekend work
• •  Flexible working hours
• •  Multicultural and friendly work environment
• •  Contribution to the Deutschlandticket (public transport ticket)
• •  Free beverages
• •  Free fruit at the workplace
• •  Free charging station for electric vehicles
• •  Employer contributions to a company pension plan
• •  Individual training opportunities
• •  High potential for personal development

Interested in New Challenges with Us?

If we have sparked your interest and enthusiasm, we look forward to meeting you. Please apply with your complete application documents (cover letter, resume, certificates), including your salary expectations and availability, via email or postal mail. Our companies comply with the legal provisions of the Equal Treatment Act (AGG) and SGB IX. All attributes in this offer equally refer to female, male, and diverse persons.

Workplace
Medipan GmbH / GA Generic Assays GmbH
Ludwig-Erhard-Ring 3
15827 Blankenfelde-Mahlow OT Dahlewitz

Your Personal Contact
Nadine Eichler (HR)
Phone: +49 33708 4417 60
Email: n.eichler@medipan.de