Quality Engineer - Medical Devices

VaudFixe2018-09-03Master / Université
Spring Life Sciences is looking for his client a

Quality Engineer - Medical Devices

Responsibilities :

• 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.
• 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).

Profile :

• 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

Votre contact

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

Merci de préciser la référence JN -062018-206536