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Supplier Quality Engineer
Katalyst Healthcares & Life Sciences
Orlando, FL (Onsite)
Full-Time
Responsibilities:
- 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
- Perform Statistical Analysis
- Product Quality Assurance
- Quality Assurance
- Quality Management Systems
- Corrective And Preventive Action (Capa)
- Statistical Process Controls
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