Supplier Quality Engineer

GENERAL SUMMARY: Provide support for Supplier Quality related activities, including managing the supplier base of 400+ contract manufacturing organization (CMO) & non-CMO suppliers, supplier audit and approval, supplier selection, qualification, corrective actions, new product development activities, and assist in Receiving Inspection operations. KEY RESPONSIBILITIES: * Actively participate in supplier selection, audits, improvement and qualification in support of existing and new products. * Participate on New Product Introductions teams to ensure suppliers meet quality, cost and delivery requirements. * Monitor, analyze, and drive improvement in supplier performance, including audit findings and SCARs. * Assist suppliers in developing and executing process validations, statistical sampling plans, inspection methodology, and process control plans. * Problem solving through classical & experimental design methods. * Provide hands-on technical support for Receiving Inspection personnel as required. * Support external supplier audits, ensure compliance to department procedures and policies and drive process improvements and efficiencies in the supplier quality department. QUALITY SYSTEMS REQUIREMENTS * In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. REQUIRED QUALIFICATIONS: * Bachelor's degree in a technical engineering field plus a minimum of 3 years experience auditing in the quality or medical device field * ASQ CQA, CQE, Lead Auditor certification to ISO 13485, Six Sigma Green Belt or Black Belt strongly preferred. * Excellent written and verbal communication skills are essential. * Requires up to 25% travel (domestic and international)

To find out more about Real please visit www.realstaffing.com [1]

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[1] http://www.realstaffing.com