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Quality Assurance Manager (f/m)

Stryker GmbH

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Quality Assurance Manager (f/m)

Lateralthinker

Quality Enthusiast

Topcolleague

Lifesaver

Quality Assurance Manager (f/m)

QA - Selzach/Kiel - Start: asap - Position permanent

Your Talent - our passion as a Top-Employer in MedTec!

33.000+ employees

Our offer
The principal activities of Quality Assurance Manager - Risk and Security, Software and Electronics are:

5.638 patents owned globally

  • Management of Risk Management Specialists, providing training, mentorship, supervision, and development
  • Resource planning and assignment of RMS resources to support R&D Projects at all T&E

$ 11.3 Billion turnover

sites
- Supervision of all Risk Management activities and documentation, providing leadership

and training, responsibility for all content

Various perspectives and

- Fulfilling the DQA role in design reviews and on design teams for software and electronics products to ensure compliance to quality system requirements (internal procedures, MDD/MDR, IEC 60601, ISO 13485, QSR, etc.) and complete documentation

possibilities for personal development

Flexible working hour arrangements

  • Participation in Quality System Audits, design file (DHF/TechFile) audits, Risk Management system audits, and Design Reviews.
  • Acting as QA approver for Design documents to ensure compliance, completeness, and

Unique and engaged colleagues

accuracy.

  • Cooperation with subject matter experts for Stryker T&E on policies, standards, and activities related to Design Development Control, Design Change Control, Design Verification and Validation, and Human Factors Engineering / Usability. Your profile
    You are a perfect candidate for the position if you have:
  • University Degree in Medical Device Technology, Mechanics, or similar.
  • 3+ years of work experience with a strong understanding of functional areas, or an equivalent combination of education & work experience in the medical industry.
  • Knowledge of IEC 60601 family, ISO 13485, ISO 14971, and QSR requirements.
  • Multiple years of experience in software/electronics development and/or in the field of quality assurance and risk management of safety related products, preferable medical devices.
  • Ability to interact ad provide feedback to R&D and operations for quality improvement, corrective actions, and quality cost reductions.

Katarzyna Gniazdek

+48 12 881 0537 www.stryker.de

We are looking forward to your online application via our career page, reference number 24307 BR. Please notice that the title of this advertisement can differ from the position title.

katarzyna.gniazdek@stryker.com

Apply now!

Stryker GmbH
Frau Valentina Kostic
Junior HR Recruiting Specialist
Bohnackerweg 1
2545 Selzach
+41 32 641 67 94