Quality Assurance Specialist (m/f)

Reference No.: 771 Tags: Jobs, Headquarters Germany, DE > Norderstedt, Other, More than 2 years practical experience

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

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. 

Your responsibilities

  • Support the product compliance activities
  • Provide quality assurance oversight and review of change control requests
  • Assume responsibility for risk management activities
  • Provide support for technology transfer activities, regulatory inspections, audits, and validation/qualification activities
  • Coordinate review and approval of quality agreements 
  • Support internal audits, supplier audits and follow-up of nonconformities and CAPA plans
  • Provide regulatory affairs assistance and support for the creation and maintenance of regulatory documents and submissions

Your profile

  • Degree in pharmacy, medicine, biology or equivalent
  • At least 2 years of practical experience in the medical technology industry, preferably in a quality assurance or regulatory affairs function
  • Good knowledge of ISO 13485 and ISO 14971
  • Proven track record of success in a relevant quality and regulatory environment
  • Excellent command of written and spoken English
  • Highly developed communication skills
  • Ability to work independently

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.

Do you have questions?

Katharina Kuboszek
Phone: +49 40 527 26 296
Sysmex Europe GmbH
Human Resources
Bornbarch 1
22848 Norderstedt
Apply now
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