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Supplier Quality Engineer at Katalyst Healthcares & Life Sciences

Supplier Quality Engineer

Katalyst Healthcares & Life Sciences Orlando, FL (Onsite) Full-Time
  • Interact with internal and external partners. Develop and execute to a supplier audit schedule per current requirements.
  • Develop audit plans and associated supplier communications. Approve and monitor Supplier Corrective Action Request (SCAR) and activities to closure including objective evidence of effectiveness.
  • Perform quality processes including change control, non-conformance and Corrective and Preventive Action (CAPA)Qualify and monitor supplier performance per established requirements. Partner with suppliers as needed to ensure their performance is acceptable per site requirements.
  • Maintain supplier files and process supplier change notifications. Coordinates with various departments (Customer Service, Technical Services, Purchasing, etc.) when qualifying and monitoring supplier performance.
  • Analyze Supplier data and present supplier metrics during Management Review meetings. Identifies and executes process improvement opportunities.
  • Must be able to explain audit results and influence other's understandings of audit observations in a tactful and professional manner.
  • Bachelor's Degree (± 16 years) in an engineering, scientific or technical discipline or an equivalent combination of education and work experience is required.
  • Minimum of 4 years of related experience in a technical or other Quality related position in a regulated industry is required.
  • FDA and ISO regulations knowledge, 21 CFR 820; ISO 13485 is preferred. SO, lead auditor certification or equivalent is preferred.

Recommended Skills

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  • Corrective And Preventive Action (Capa)
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