Quality Engineer II

The ideal candidate for this Quality Engineer position will have experience of working to Medical Device standards (ISO 13485 and 21 CFR 820) as the successful applicant with be supporting customers in that sector. Candidates with experience of working to Aerospace standards (AS9100 and ISO 9001) would also be considered. Purpose Statement: The Quality 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 deviations from 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 external customer audits and internal audit activities. Support recertification and surveillance QMS audits. Lead product-related 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 SMEs to address customer quality concerns. Lead creation of customer defined quality reports. Lead CAPA development in response to customer request. 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 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 PPQP activities. * Continuous Improvement: Lead continuous improvement efforts to improve outgoing yield and customer 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 CRG. Collaborate with the Process and/or Product Engineer to implement improvements. Lead CAPA development for repeat or systemic issues; ensure implementation. Additional Accountabilities: * 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. Education/Experience Qualifications: * 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. Other Qualifications: * Ability to work well in fast-paced manufacturing environment. * Strong ability to identify and solve problems proactively using structured problem solving tools, including making timely and effective decisions. * Apply systemic data analysis and problem solving to address a full range of technical and organizational problems with creativity, imagination, confidence and responsibility. * Ability to design and conduct experiments, as well as to analyze, interpret, validate, and communicate data to key stakeholders. * Ability to seek out best practices and apply them within their assigned area. * Ability to apply knowledge, logic and reasoning using mathematics, statistics, science, and engineering applications. * Ability to design a system or process to meet desired needs within realistic constraints such as economic, efficiency, repeatability, envi