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

Date Posted: 7/21/2020

Job Snapshot

Job Description

As a Senior Design Assurance Engineer (m/w/d) you will join the T&E Design Quality Assurance Sustaining team and you will act as an independent interface mainly between Manufacturing, Quality Operations, R&D Technical Office, Regulatory Affairs, Biomechanics, PMS within the Stryker T&E Division, ensuring full compliance to any internal and external requirement.

Your key responsibilities

  • Responsible of providing support to Global Quality and Operations projects: mainly manufacturing transfers within the Stryker T&E division
  • Supporting the DQA line manager in evaluating feasibility for standard/non-standard reworks across multiple international T&E manufacturing sites
  • Ensuring the highest level of quality is built into products in accordance with internal and external requirements
  • Evaluating and approving Engineering Design Change Requests.
  • Review technical documentation to support legacy care activities and eventually any regulatory submission/international registration.
  • Reviewing and approving final design verification and validation activities in collaboration with the testing laboratory and R&D Technical Office.
  • Leading risk management activities by identifying risks and how the design, labeling and manufacturing processes can help mitigating risks as far as possible.
  • You will use your analytical and technical skills to evaluate any design quality issue that arises and initiate appropriate corrections/corrective actions to resolve them.

What are we looking for?

  • You have successfully completed a Master of Science in Mechanical Engineering or Biomedical/Electrical Engineering
  • You have several years of professional experience, ideally in design quality assurance or product development of medical devices or any other highly regulated industry
  • You are ideally an ASQ Certified Quality Engineer or Certified Biomedical Auditor.
  • Furthermore, you have a sound knowledge and understanding of risk management concepts, Design Control, Change Control and Quality Engineering tools (EN ISO 14971, EN ISO 13485)
  • Your profile is completed by excellent communication skills: Fluency in English is mandatory. Fluency in German is strongly preferred.

Contact

In case you have further questions regarding the position, please feel free to directly reach out to Lisa Buch via + 49 175 8061763.

Work From Home: Occasional

Travel Percentage: 10%

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