Design Quality Engineer

VaudPermanentConstruction, Craft, Electrics2019-05-15Higher Professional Education / Certificate
Spring Life Sciences is looking for his client a:

Design Quality Engineer

Your challenges

  • Apply knowledge of design, control principles and quality engineering techniques.
  • Providing support and guidance for the R&D teams to ensure the design process, design reviews, verification and validation, risk management activities as well as design transfer from R&D to the installation, which are then executed and documented.
  • Support the R&D teams, ensuring that the design change control is documented.
  • Create Risk Management tools and documents and qualify the employees.
  • Generate Standard Operation Procedure and Work Instructions according to 21 CFR 820, 21 CFR 11 and ISO 13485 requirements.
  • Support the evaluation and validation of product and process test methods together with the Quality Engineer Process.
  • Support the Document Control to generate Standard Operation Procedure, Work instruction as well as formulary.
  • Review verification and validation documentation to ensure regulatory requirements and quality objectives are met.
  • Support the R&D Team to generate and close NC, CAPAs supervise these deviations true the whole design process (Risk Management).
  • Ensure that all topics are according to 21 CFR 820, 21 CFR 11 and ISO 13485 requirements, and follow internal processes, procedures, forms and templates.


Your skills

  • Experience with Quality Engineering, Manufacturing Engineering, and/or Engineering design.
  • Experience with Quality Management System (QMS).
  • Experience with electronics assembly, machining, and mechanical assembly operations.
  • Experience with statistical tools.
  • Strong analytical and problem-solving skills.
  • Good communication skills.
  • Experience with ISO 13485 and 21 CFR 820 compliance and implementation.
  • English and French


Your contact

Are you interested in this job? You can apply directly online, or by eMail.

Please mention reference JN -052019-295984 in your application

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