(Senior) Design Quality Engineer (m/w/d) in Selzach at Stryker Corporation

Date Posted: 3/16/2020

Job Snapshot

Job Description

Your key responsibilities

  • As a (Senior) Design Quality Engineer you will join the Quality Assurance Sustaining team and act as an independent interface mainly between R&D Technical Office, Regulatory Affairs, Biomechanics and Global Operations within the Trauma and Extremities Division.

  • You are responsible for ensuring the design quality of the legacy portfolio and new developed custom made devices to ensure the highest level of safety, product quality as well as regulatory compliance.

  • ​You ensure that medical device files are maintained according to in internal and external requirements.

  • Furthermore, you are responsible for reviewing, contributing and approving technical deliverables and documentation regarding design changes, design verification and validation.

  • You will lead the risk management process and support international product registrations in key target markets for the T&E Division.

  • You will use your analytical and technical skills to evaluate any design quality issue that arises and initiate appropriate corrective actions to resolve them.

  • In this role, you will also support product manufacturing transfers to internal and/or external manufacturing facilities in collaboration with our global operations and internal partners.

What are we looking for?

  • You have successfully completed a Master of Science in Mechanical Engineering or Biomedical/Electrical Engineering or any related scientific degree (i.e. Microbiology). A PhD is desirable, but not essential.

  • You have several years of professional experience, ideally in quality assurance or product development of medical devices

  • You are ideally an ASQ Certified Quality Engineer or Certified Six Sigma Green Belt or Certified Quality Auditor

  • Furthermore, you have experience and a strong understanding of risk management concepts, Design Control and Quality Engineering tools such as FMEA and Root Cause Analysis.

  • You are characterized by strong project management skills, a structured way of working as well as strong analytical and conflict management skills.

  • Your profile is rounded off by your very good written and spoken English skills. German language skills are desirable.

Contact

In case you have further questions regarding the position, please feel free to directly reach out to Lisa Buch via lisa.buch@stryker.com

Work From Home: Occasional

Travel Percentage: 0%

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