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Quality Assurance Manager (f/m/d)

Reference No.: 4154 Tags: Jobs, Headquarters Germany, DE > Norderstedt, Other, More than 2 years practical 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 Assurance Manager (f/m/d)

Temporary 2 years

Your responsibilities

  • Support the maintenance and development of our regional headquarter quality management system (EN ISO 13485)
  • Prepare, execute and follow up internal, external and supplier audits
  • Consult and support other departments regarding quality management requirements with a focus on product related topics, e.g. design and development process
  • Support the Regulatory Affairs team and other departments regarding Risk Management as per ISO 14971
  • Execute and monitor the Product Change Control process
  • Lead or participate in quality management improvement projects
  • Support conducting trainings for new employees, internal auditors and QM coordinators

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
  • Knowledge of ISO 14971, preferably medical device industry regulatory requirements
  • Initial experience in IVD-production environment preferred
  • Audit experience
  • Project management skills and experience preferred
  • Process improvement skills
  • Excellent command of written and spoken English
  • Good communication skills and the ability to make decisions in a consistent and professional manner
  • Ability to work independently

We offer

  • A growing and healthy corporate group with respect and trust as the basis for cooperation and communication
  • A family atmosphere as well as innovative working in an international environment
  • 30 days annual holidays and Christmas bonus/holiday pay
  • Capital-forming benefits and subsidy towards the company pension scheme
  • Flexible working times/flexitime as well as the possibility of working from the home office
  • Subsidy towards the public transport “ProfiTicket”, free parking for all employees
  • Diverse range of sports in our own fitness studio/massage
  • Canteen/free beverages/fruit

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?

Ute Heitmann
Phone: +49 40 527 26-296
Reference No.: 04154

Sysmex Europe GmbH, Bornbarch 1, 22848 Norderstedt
Apply now
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