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Randstad (Schweiz) AG

Supplier Quality Engineer

100% Fachverantwortung 22.01.2019
Supplier Quality Engineer

Randstad Professionals is currently looking for an Supplier Quality Engineer who will be assigned an interesting challenge for a major client based in the Solothurn area. This contract is an unique opportunity to join a major client, global group focusing on the Healthcare sector (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will start immediately and will last until December 2019.

Job description:

Project Goal: To ensure all externally manufactured meet new EU MDR requirements. Collaborate with suppliers to obtain details for manufacturing process information, production risk management and direct part marking. This information will be used to update the product's technical file to be in compliance with Medical Device Regulations.

Deliverables: The EU MDR SQE will evaluate the supplier's manufacturing process information, production risk management, direct part marking documentation against MDR Requirements; collaborate with the supplier to revise existing or develop new manufacturing process information, production risk management and/or direct part marking documentation as applicable.

Your key responsibilities will include

  • Become a working member of the technical file remediation efforts to ensure externally manufactured products meet EU MDR requirements. This includes supporting project deliverables; meeting project timelines; resolving identified supplier issues and executing the overall project related to technical file remediation requirements.

  • Assess supplier drawings and process information to support project deliverables:

    • Manufacturing Process Information

    • Production risk management file

    • Validation protocols and reports

    • Direct part marking documentation

  • Work with Suppliers to meet EU MDR requirements and resolve issues with obtaining Supplier Product information.

  • Cross coordinate Workstream activities/interdependencies with other workstream and project teams.

  • Partner with Supply Chain to support EU MDR supplier communications and rollout of EU MDR Supply Chain Workstream activities;

  • Support definition and clarification of EU MDR supplier related process requirements.

  • Support Review and Approval EU MDR Change Projects as applicable.

  • Support Supplier Quality Functional Impact Assessments as applicable.

  • Support Review and Approval of supplier Process Validation Protocols and Reports as applicable.

  • Support the update of supplier related Inspection Criteria as applicable.

The following skills and experience is required:

  • A minimum of a bachelor's degree or equivalent in engineering or associated technical field is required.

  • A minimum of 3 years' experience in a quality engineering is required.

  • A minimum of 2 years' experience in the medical device and/or pharmaceutical industry is required.

  • Familiarity with ISO 13485 and FDA QSR is required.

  • Excellent organizational skills and attention to detail is required.

  • Must be able to work independently and prioritize with limited supervision.

  • Strong written and oral communication and interpersonal (listening) skills.

  • Excellent computer, communication, and written skills are required. Proficient in Microsoft Office suite is required.

Experience and knowledge preferred:

  • Three years' experience as Supplier Quality engineer; Supplier Process Validation engineer; Project Engineer, Project Manager or equivalent role within regulated industry.

  • Understanding supplier management and validation procedures and execution.

  • Strong background in Medical Device Regulatory Compliance/Regulatory Affairs.

  • Experience working with suppliers across multiple sites and franchises.

  • Ability to act as an SME in supplier business processes.

  • Experience with medical device technical files.

Gesamtbewertung

3,4

Basierend auf 16 Bewertungen

2,5 Karriere / Weiterbildung
2,5 Gehalt / Sozialleistungen
3,0 Work-Life-Balance
3,0 Management

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