Career Opportunities

Medanex is a fast growing company and continuously looking for talent. Please let us know if you’re interested to join our team!

Job Opportunity

Quality Assurance Manager Preclinical Medical Device Studies

About Medanex Clinic:

Medanex Clinic is a global leader in surgical preclinical research in large animals for human applications. As CRO, we provide services, expertise and facilities to international R&D companies and universities for research, development and training on innovative human medical devices & therapies. Our capabilities are unique and appreciated by our clients worldwide. Compliance with the highest international quality standards is crucial in our work and therefore Medanex Clinic is fully GLP-accredited.

To support our growing activities, we are looking for an in-house Quality Assurance Manger to maintain and expand our GLP activities, together with our skilled team of study directors, veterinarians, scientists,  biotechnicians and animal caretakers. The QA manager will have a leading role in all quality-related matters, supported by external consultants if needed.

Medanex Clinic provides, as SME, a supportive working environment in which the QA Manager can deploy his or her entrepreneurial and leadership capacities.

We seek:

An experienced QA manager who wants to step into cutting-edge preclinical animal research for human applications, eager to learn, passionate about medical research and development.

Your responsibilities will be:

  • Maintain, manage and improve the current GLP status of Medanex Clinic as Test Facility
  • Perform internal audits of the facility and GLP studies
  • Coordinate external audits from the GLP Monitorate, FDA, notified bodies and customers
  • Implement and expand the GLP principles in new processes
  • Advise clients on quality-related aspects of their studies
  • Stay up-to-date with international medical device regulations
  • Share your knowledge and insights; take opportunities for process improvement and implementation of new guidelines in the workflows

Profile:

  • You hold an academic degree in medical, biomedical, veterinary, pharmaceutical sciences, bioengineering or equivalent education.
  • You have preferably more than 5 years of experience in a quality-related role in pre-clinical research of medical devices.
  • You preferably have experience in a CRO setting.
  • Knowledge of regulatory affairs is an asset.
  • You are communicatively skilled to face clients and to interact with a diverse audience, including animal caretakers, biotechnicians, experts and management.
  • You are an entrepreneur, taking ownership. You have the ability to multi-task and maintain organization in a fast paced, rapidly changing environment.
  • You have verbal and written communication proficiency in English; the ability to read, analyze, understand, discuss and interpret complex scientific and regulatory documents. You are able to effectively communicate scientific data and conclusions.
  • MS Office has no secrets to you

We offer:

  • An innovative and inspiring job opportunity in the attractive Medanex Clinic facilities in Diest (Belgium), in daily contact with multinationals & start-ups.
  • Opportunities for self-development, in a well-organized facility structure.
  • A pleasant and diverse work environment with the entrepreneurial can-do attitude of an SME, providing warm welcomes and support.
  • Competitive remuneration.

Triggered? Apply Now!

  • Go to medanex.com and send your cv and tailored letter via e-mail to Info@medanex.com .
  • Do not hesitate to contact +32 13 67 35 00 in case you have further queries.