Quality Assurance Specialist
hace 3 semanas
Plexus is seeking a highly skilled Quality Assurance Specialist to lead the determination of non-conformance and customer complaints through containment, root cause, corrective action, and audits. The successful candidate will ensure product compliance to customer specifications and industry standards.
Key Responsibilities- Compliance: Ensure products comply with customer specifications, industry standards, regulatory requirements, and Plexus standards. Approve all changes and deviations from established guidance, including Engineering Change Orders (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 external customer audits and internal audit activities. Support recertification and surveillance Quality Management System (QMS) audits. Lead product-related Corrective Action and Preventive Action (CAPA) discussion and closure.
- Quality Assurance: Ensure continuous quality compliance during manufacturing operations. Monitor on-going manufacturing operations to ensure quality issues are quickly addressed; provide quality alerts and lead containment and purges, when required. Lead the development of the inspection strategy for 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 quality history documentation, as required.
- Customer Support: Serve as the primary customer contact for quality-related issues, including specification inquiries and audits. Lead response and actions associated with customer quality concerns, including complaints, disclosures, and inquiries. Engage the Process and/or Product Engineer and other Subject Matter Experts (SMEs) to address customer quality concerns. Lead creation of customer-defined quality reports. Lead CAPA development in response to customer requests. Provide feedback and documentation to the customer, as required.
- Manufacturing Readiness: Create and maintain all required quality guidance for manufacturing readiness, including Quality Plans. Lead identification and maintenance of customer and industry standard failure modes for inclusion in the Product Failure Mode and Effects Analysis (FMEA). 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 quality-related Process Performance and Product Quality Planning (PPQP) activities.
- Continuous Improvement: Lead continuous improvement efforts to improve outgoing yield and customer Parts Per Million (PPM) to reduce Cost of Quality in order to deliver customer excellence and achieve Plexus' enduring goals. Lead analysis of quality metric data and identify opportunities to reduce scrap, rework, and Customer Return Goods (CRG). Collaborate with the Process and/or Product Engineer to implement improvements. Lead CAPA development for repeat or systemic issues; ensure implementation.
- Lead initial investigation and disposition decisions for Non-Conforming Material (NCM).
- Support Receiving Inspection Team requests for clarification on documentation or acceptability requirements.
- Lead determination of Q and R codes.
- Minimal travel may be required to meet the needs of the business (estimated 10%).
- Additional duties as assigned.
- A minimum of a Bachelor's degree is required; a Bachelor's degree in Engineering is preferred.
- Five (5) years of related experience is required; Two (2) or more years of related experience is preferred.
- An equivalent combination of education and experience sufficient to successfully perform the key job accountabilities may be considered.
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