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Supplier Quality Engineer Career Profile

Supplier Quality Engineer


A supplier quality Engineer is responsible for carrying out quality audits on supplier sites and service providers t omedical device companies

Key Responsibilities

  • Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
  • Responsible for developing, applying, revising and maintaining quality standards for SQA / Purchasing Control activities in compliance with CFPs / CFMs etc
  • Liaise with Supplier development and Strategic sourcing in the maintenance & performance of suppliers
  • Perform supplier assessments to support the approval and on-going maintenance of suppliers
  • Ensure & support, through review & approval of, the appropriate qualification of Item & Service providers
  • Partakes in the review and approval of specifications, inspection reports and part number set-ups required for the successful completion of raw material inspections
  • Provide support at a local level in the assessment of quality impact of a supplier
  • Establish and maintain supplier quality agreements for local suppliers. Supports supplier improvement projects
  • Establish and maintain metrics reflecting the performance of local/direct suppliers to facilitate supplier monitoring and improvement
  • Drive supplier non conformances to closure in a timely manner through the non conformance process
  • Communicate non-conformances to suppliers through Supplier Corrective Action Report (SCAR) process and ensure timely closure of all open actions
  • Present supplier metrics and escalation of issues to Quality and Management review
  • Responds to and participates in corrective action implementation for identified internal audits
  • Participates in investigation/corrective action efforts during production interruption circumstances
  • Review and approval of the completed Batch Record Files to assure correct disposition of inspected materials as required
  • Liaise with Operations, Supply Chain Management, Warehouse, Engineering and NPD to ensure uninterrupted supply of materials

Skills/Experience

  • Over 8 or more years of related experience and/or training; or equivalent combination of education and experience
  • Experience in supplier management is essential with a knowledge of problem solving methodologies