Roche

Device Supplier Quality Manager

Roche

full-time

Posted on:

Location Type: Office

Location: Basel • Switzerland

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About the role

  • Collaborates with device and packaging development, device industrialization as well as device project teams in a matrix organization.
  • Quality assurance oversight of external GxP suppliers including CMOs to ensure compliance with regulations, standards and Roche requirements.
  • Oversight of all required quality activities during the lifecycle of a GxP supplier.
  • Coordination of the Quality support for medical devices and drug-device combination products between Global Device Quality and the local QA/QC teams at Roche plants.

Requirements

  • You hold a degree in an Engineering or Science discipline with a thorough understanding of the biotechnology industry and specifically of combination products and medical devices.
  • Working knowledge of ISO 13485, 21 CFR 820, EU MDR and ISO 14971.
  • Sound understanding of Quality Compliance, Quality Engineering, and Audits & Inspections Management.
  • Ability to educate teams and organization on Design Controls as it applies to medical devices and combination products, and related topics.
  • Demonstrated capability of applying risk management concepts and tools.
  • Well-developed teamwork and collaboration skills and ability to communicate clearly and professionally both verbally and in writing.
  • Fluency in English (Fluency in a second language is a plus).
  • Demonstrated problem solving and decision-making skills including hands-on working experience with quality-related tools, Six Sigma / DMAIC.
  • Experience in working in agile environment and usage of lean tools.
  • This position requires up to 30% travel.
Benefits
  • This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come.
  • Join Roche, where every voice matters.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
ISO 1348521 CFR 820EU MDRISO 14971Quality ComplianceQuality EngineeringAudits & Inspections ManagementDesign Controlsrisk managementSix Sigma
Soft Skills
teamworkcollaborationcommunicationproblem solvingdecision-making