Supplier Quality Engineer

SUMMARYMaintain the quality system and support supplier and incoming quality through the use of engineering tools and methodologies in order to support production, design, and development of medical devices.RESPONSIBILITIESWork with suppliers and the Purchasing department to address quality issues with raw materials and componentsMaintain supplier approvals and certificationsReview supplier quality agreementsMake use of statistical techniques, risk analysis, Gage R&R, Cpk, ANOVA and DOESolve problems using Cause & Effect diagrams, Failure Mode Effect Analysis, Root-Cause, 5-Why, 8DMaintain Quality RecordsPerform Corrective Actions and Non-conformance assessmentsPerform supplier audits as well as internal auditsSupport Incoming InspectionReview Work Instructions, Quality Plans, FMEAs, specifications, drawings, quality systems and analysis trendsParticipate in and lead continual improvement projectsTravel up to 25% required for supplier support and auditsQUALIFICATIONSBachelor’s Degree in Industrial, Mechanical or Biomedical engineering or equivalent experience.At least 5 years of experience working with suppliers in the medical device industry.Very good written and verbal communication skills.CQA or certified biomedical auditor certification helpful but not required.Experience with supplier audits and supplier management.Experience with quality management systems standards (ISO13845, ISO9001, AS9100)Accuracy, thoroughness, attention to detail, legibility in completing records is essential.Lean and 6 Sigma knowledge a plus.COMPENSATION : $85,000-$120,000

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