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
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Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
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Responsible for developing, applying, revising and maintaining quality standards for SQA / Purchasing Control activities in compliance with CFPs / CFMs etc
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Liaise with Supplier development and Strategic sourcing in the maintenance & performance of suppliers
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Perform supplier assessments to support the approval and on-going maintenance of suppliers
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Ensure & support, through review & approval of, the appropriate qualification of Item & Service providers
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Partakes in the review and approval of specifications, inspection reports and part number set-ups required for the successful completion of raw material inspections
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Provide support at a local level in the assessment of quality impact of a supplier
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Establish and maintain supplier quality agreements for local suppliers. Supports supplier improvement projects
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Establish and maintain metrics reflecting the performance of local/direct suppliers to facilitate supplier monitoring and improvement
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Drive supplier non conformances to closure in a timely manner through the non conformance process
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Communicate non-conformances to suppliers through Supplier Corrective Action Report (SCAR) process and ensure timely closure of all open actions
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Present supplier metrics and escalation of issues to Quality and Management review
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Responds to and participates in corrective action implementation for identified internal audits
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Participates in investigation/corrective action efforts during production interruption circumstances
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Review and approval of the completed Batch Record Files to assure correct disposition of inspected materials as required
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Liaise with Operations, Supply Chain Management, Warehouse, Engineering and NPD to ensure uninterrupted supply of materials
Skills/Experience
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Over 8 or more years of related experience and/or training; or equivalent combination of education and experience
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Experience in supplier management is essential with a knowledge of problem solving methodologies