Senior Quality Project Engineer

VaudFixeChimie, Pharma, Biotechnologie2019-05-01Master / Université
Our client, an important Medical Device company based on innovation is recruiting a senior project engineer to strenghten their quality team

Senior Quality Project Engineer

Your Responsibilities

Quality Engineering :
  • Ensure the conformity of the design development per procedure.
  • Ensure Production/Design Transfer support per procedure.
  • Participate to the definition of norms and standards for the different projects.
  • Ensure risk assessment (design & process) review per procedure.
  • In charge of quality aspects for new product (development) and product released in production (dFMEA - pFMEA - VMP - IQ, OQ, PQ and change management).
  • Contribute to the review of DHF, DMR, DHR.

Quality Assurance
  • Lead and follow up nonconformities (internal, supplier).
  • Lead and follow up customers complaints.
  • Participate in supplier management (homologation and monitoring).
  • Participate to internal audit and supplier audit.
  • Lead quality training in the all company.
  • Participate to the process improvement including procedures creations and updates.
  • Participate to maintain the QMS (documentation control).

Your Profile

  • Master of Science
  • Minimum 5 years experience within the medical device industry
  • Minimum 3 years experience in quality project management
  • 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 mandatory

Votre contact

Etes-vous intéressé(e)? Vous pouvez postuler soit en ligne, soit par eMail.

Merci de préciser la référence JN -052019-295800