Product Quality Engineer

Product Quality Engineer

Distalmotion

Épalinges, Switzerland

Support Product & Supplier Quality team integrated in QA/RA department on product quality activities, for Distalmotion (DM) products (sterile instruments, Dexter robot system and its accessories, other products used with Dexter system), manufactured at contracts manufacturers (CMO) and suppliers, as main activities, and partially supplier quality activities, as above described.

Duties and Responsibilities:

Product quality activities:

• Manage and follow internal/process non conformities.
• Define and participate on continuous improvements of DM products and processes.
• Support on CAPA investigations and implementation of internal actions.
• Collaborate on Product KPIs monitoring, data trend analysis and create Product Quality Reviews reports.
• Collaborate on pFMEA/process validations documentation reviews.
• Collaborate and follow on product release process.
• Collabore on changes and design transfers to CMOs/suppliers.
• Contribute on needed changes on ERP/QMS systems (new/update test plans, QA items configuration, QMS procedures, work instructions and forms).

Supplier Quality activities:

• Manage and execute suppliers’ qualification audits according to audit plan.
• Support new CMO/suppliers implementation according to DM requirements and procedure.
• Support SQE on 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.

Work Experience and Education requirements:

• Bachelor’s degree in an engineering science (mechanical, electronics) or quality.
• 3-4+ years’ experience in Supplier Quality, Quality Control, or Manufacturing engineering within the Medical device industry or similar.
• Experienced/trained on ISO 13485 and 9001 standards and as external auditor on these standards.

Knowledge, Skills & Abilities required:

• 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 &/or German a plus.
• Open to travel – around 10% for partial supplier quality activities.

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