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Supplier Quality Engineer

Company: AO
Location: sheboygan
Posted on: May 3, 2021

Job Description:

Job Summary:Lead efforts to ensure Product Quality and Regulatory compliance of AO suppliers. Assist New Product Development Teams and other functions regarding supplier selection and qualifications. Assist Suppliers and Operations driving continuous improvements.Duties & Responsibilities:Support New Product Development, Marketing and Procurement in the selection of SuppliersDefine Quality and Regulatory requirements for current and potential new suppliersReview compliance of suppliers and support documentationsMaintain database of supplier contract templates and agreementsLead Supplier Quality activitiesManage Supplier non-conformances and Supplier Corrective ActionsMonitor and drive continuous improvements of current suppliersLead or assist implementing Quality Controls and Supplier verification activitiesEnsure and assist suppliers at maintaining regulatory complianceEnsure all suppliers maintain proper registration and certificationsEnsureall key suppliers have completed and communicated the technical and regulatory information (Post Market Surveillance, Clinical Evaluation Report, Risk Management Files, Technical Files)Reviewand define the necessary documentation, registration, and certification per category of suppliers (OBL, Distributor, Contract Manufacturer)Maintain current knowledge base of existing and emerging regulations, standards, or guidance documentsIdentify relevant guidance documents, international standards, or consensus standard and provide interpretive assistanceInterpretregulatory rules or rule changes and ensure the rules and changes are communicated through corporate policies and proceduresObtainand distribute information regarding domestic or international laws, guidelines, or standardsParticipate in internal and external auditsWrite and/or update Quality Management System procedures, standard operating procedures, work instructions, Quality Manual or policiesPerform additional responsibilities as requested to achieve business objectivesQualifications:Bachelor's Degree in Engineering from a four-year college or university requiredExperience with medical devices or other highly regulated industries/products desiredDemonstrate strong internal structure to successfully lead multiple activities simultaneouslyDemonstrate accuracy and thoroughnessAbility to interpret regulations and apply the regulations to the organizationStrong written and verbal communication skillsMust be able to stand, walk and/or sit for up to 8-10 hours per dayMay require occasional early morning or late evening teleconferences

Keywords: AO, Sheboygan , Supplier Quality Engineer, Other , sheboygan, Wisconsin

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