Product & Supplier Quality Engineer

Product & Supplier Quality Engineer

Distalmotion

Épalinges, Switzerland

You are looking for a new fulfilling challenge in a fast-growing medical device company? Join a team engaged in making on-demand robotic surgery the new medical revolution.

About Product & Supplier Quality Engineer

Support Product & Supplier Quality department on supplier quality activities namely suppliers’ qualification process and product quality activities for Distalmotion manufacturing lines for sterile instruments, Dexter robot system and its accessories.

Tasks

Supplier Quality:

  • Manage and execute suppliers’ qualification audits and related audits follow up according to audit plan;
  • Ensure suppliers’ management activities according to standard DM procedure;
  • Manage nonconformities from suppliers (audits, incoming, production issues) and CAPA plans defined by suppliers and follow up.

Product quality:

  • Contribute on needed changes on ERP/QMS systems (new/update inspection plans, QA items configuration, procedures);
  • Define and participate on continuous improvements of our products and processes (lean six sigma, etc.);
  • Participate on monitoring CMOs KPIs, data trend analysis and Product Quality Reviews.

Requirements

  • Bachelor’s degree in an engineering science (mechanical, electronics) or operational quality;
  • 4-6+ years’ experience in Design or Manufacturing engineering within the Medical Device industry or similar;
  • External Lead Auditor certificate to perform audits according to ISO 13485 and 9001;
  • Experienced/trained on ISO 13485 and 9001 standards;
  • Experience in non-conformities and CAPA management;
  • Proven experience on KPI measurement, quality reports and data trending/analysis;
  • Manufacturing and engineering skills - knowledge of manufacturing and production processes, process enhancement (provide guidance on improving process efficiency while maintaining a high level of quality, safety, and reliability);
  • Excellent written and verbal in-house and external communication and liaison skills;
  • English Fluent, French & German a plus;
  • Open to travel – up to 30% (all world).

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