Supplier Quality Engineer

Location: Boston, Massachusetts Salary: competitive
Sector: Pharma & Biotech, Medical Devices, Engineering, Quality & Supply Chain, Engineering & Validation, Quality Assurance (QA), Operations Type: Contract

I'm supporting a large Medical Device client in the Greater Philadelphia area to secure a Supplier Quality Engineer for a 2 year EU MDR project. This will be a 100% on site role.

This position is paying from $50-$70 an hour (all-inclusive) depending on experience and interviews are commencing on 18th & 19th February.

Key Responsibilities:

  • 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.

Knowledge and experience required:

  • 3+ years' experience as Supplier Quality engineer; Supplier Process Validation engineer; Project Engineer, Project Manager or equivalent role within the Medical Device industry
  • Understanding supplier management and validation procedures and execution.
  • Experience working with suppliers across multiple sites and franchises.
  • Ability to act as an SME in supplier business processes.


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