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Quality Management System Manager (f/m/div)

Reference No.: 2386 Tags: Jobs, Headquarters Germany, DE > Norderstedt, Administration, More than 2 years of professional experience

Place of work: Bornbarch 1, 22848 Norderstedt, (near Hamburg), DE

Are you looking for more than just a job? Something truly significant and worthwhile? Then Sysmex is the right place for you. Our products are needed. By people all over the world, for a healthy life.
If this appeals to you, come and join us in the position of

Quality Management System Manager (f/m/div)

Your responsibilities

  • Be part of the Sysmex Europe Quality Team
  • Maintain and further develop our regional headquarter quality management system (EN ISO 13485)
  • Prepare, execute and follow up internal, external and supplier audits
  • Ensure compliant and up to date quality management documentation
  • Conduct trainings for new employees, internal auditors and QM coordinators
  • Lead or participate in quality management improvement projects
  • Consult and support other departments regarding quality management topics
  • Communicate with suppliers and global headquarters regarding quality management topics
  • Support the reporting on the performance of the quality management system to regional headquarter management and global headquarter
  • Closely work together with our Regulatory Affairs team

Your profile

  • Degree in a relevant discipline, e.g. medical technology
  • At least 3 years of experience in a quality management function, preferably in
    the medical devices industry
  • Substantial knowledge of EN ISO 13485, good knowledge of ISO 14971, preferably medical device industry regulatory requirements
  • Training skills
  • Project Management skills
  • Process improvements skills
  • Initial audit experience preferred
  • Excellent command of written and spoken English
  • Good communication skills and the ability to make decisions in a consistent and professional manner

We offer

  • A growing and healthy corporate group which stands for quality and innovation
  • A strong corporate culture with respect and trust as the basis for cooperation and communication
  • A challenging and multifaceted position with numerous chances to see the bigger picture and contribute to the company’s success in an innovative international environment

Did we spark your interest? Then we look forward to receiving your application with salary requirements and the earliest possible starting date.

Our Company

The highest quality of healthcare: As a multinational company Sysmex has been developing, producing and selling medical analytical devices and IT solutions for the lab sector worldwide for 50 years. With more than 1,000 employees in Germany, we live by the philosophy of “Shaping the advancement of healthcare“ every day. 

Do you have questions?

Katharina Kuboszek
Phone: +49 40 527 26 296
Reference No.: 02386
 
Sysmex Europe GmbH, Bornbarch 1, 22848 Norderstedt
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