Full Description

Purpose Statement: The Quality Engineer Sr ensures products comply with customer specifications, industry standards, regulatory requirements and Plexus standards. They will ensure Assembly Build Instruction (ABI)s comply with specifications and standards. Approve all changes and deviations from established guidance, including Engineering Change Order (ECO)s. Lead creation and maintenance of the Master Validation Plans, when required, and ensure compliance. Support creation and execution of documents for New Product Introduction (NPI). 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 and Preventive Action (CAPA) discussion and closure.

Key Job Accountabilities

• 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 Corrective and Preventive Action (CAPA) development in response to customer request. Provide feedback and documentation to the customer as required.
• Provide technical training, leadership, guidance and direction to regional and site management and stakeholders.
• 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.
• Yield 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 Clinical Risk Group (CRG)s. Collaborate with the Process and/or Product Engineer to implement improvements. Lead Corrective and Preventive Action (CAPA) development for repeat or systemic issues as well as ensuring implementation.
• Provide support and leadership in order to effectively design, develop, monitor, maintain, and continuously improve the quality management system in alignment with Plexus strategies and values to ensure services are capable of meeting business needs.

Education/Experience Qualifications

• Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or equivalent work experience.