.Purpose Statement:The Engineer leads determination of non-conformance and customer complaints through containment, root cause, corrective action, and audits. They ensure product compliance to customer specifications and industry standards.Key Job Accountabilities:Compliance:Ensure products comply with customer specifications, industry standards, regulatory requirements and Plexus standards. Ensure ABIs comply with specifications and standards. Approve all changes and deviatioom established guidance, including ECOs. Lead creation and maintenance of the Master Validation Plans, when required; ensure compliance. Support creation and execution of IQ OQ PQ protocols to ensure compliance with the Master Validation Plan. Serve as the Plexus lead to support rnal customer audits and internal audit activities. Support recertification and surveillance QMS audits. Lead product-related CAPA discussion and closure. Assurance:Ensure continuous compliance during manufacturing operations. Monitor on-going manufacturing operations to ensure issues are quickly addressed; provide alerts and leadcontainment and purges, when required. Lead the development of the inspection strater receiving inspection, pre-ship inspection, and out-of-box-audits. Ensure Certificates of Compliance are created and maintained, including documentation of deviations. Ensure creation and maintenance of manufacturing history documentation, as required.Customer Support:Serve as the primary customer contar -related issues, including specification inquiries and audits. Lead response and actions associated with customer concerns, including complaints, disclosures, and inquiries. Engage the Process and/or Product Engineer and other SMEs to address customer concerns. Lead creation of customer defined reports. Lead CAPA development in response to customer request. Proviedback and documentation to the customer, as required.Manufacturing Readiness:Create and maintain all required guidanr manufacturing readiness, including Plans. Lead identification and maintenance of customer and industry standailure modr inclusion in the ProduEA. Support development, execution and maintenance of the Control Plan to ensure compliance with customer specifications, industry standards, and regulatory requirements and Plexus standards. Ensure customer specifications are included in training, as required. Lead -related PPQP activities.Continuous Improvement:Lead continuous improvement efforts to improve outgoing yield and customer PPM to reduce Cost of in order to deliver customer excellence and achieve Plexus enduring goals. Lead analysis of metric data and identify opportunities to reduce scrap, rework and CRG. Collaborate with the Process and/or Product Engineer to implement improvements. Lead CAPA developmer repeat or systemic issues; ensure implementation.Additional Accountabilities:Lead initial investigation anddisposition decisior Non-Conforming Material (NCM)