The Quality Engineer is responsible for the day-to-day Quality Management System (QMS) activities associated with the product life cycle of high-reliability product design and development, ensuring compliance to customer specifications and industry standards.
To be successful in this position, it is critical that the Quality Engineer has a thorough understanding of the use and application of standards and specifications, including ISO 9001, AS9100, Nadcap, ITAR, ISO 13485, ISO 14971, and FDA 21CFR Part 820.
Essential Duties:
Regulatory & Compliance
• Ensure products comply with customer specifications, industry standards, regulatory requirements and Plexus standards. Ensure ABIs comply with specifications and standards.
• Approves all changes and deviations from established guidance, including ECOs.
• Leads creation and maintenance of the Master Validation Plans, when required; ensure compliance
• Support creation and execution of qualification and validation protocols (Ex: IQ/OQ/PQ) protocols to ensure compliance with Master Validation Plans
• Serve as the lead to support customer audits and internal audit activities including support of recertification and surveillance QMS audits
• Lead product related CAPA discussions, investigations, and closures
Quality Assurance
• Ensure continuous quality compliance during manufacturing operations
• Monitor on-going manufacturing operations to ensure quality issues are addressed timely and provide quality alerts, product containments and purges when/as required
• Lead the development of the inspection strategy for incoming/receiving, in-process manufacturing, pre-shipment inspection, and out-of-box-audits
• Support Certificates of Compliance creation and maintenance including documentation of deviations
• Ensure creation and maintenance of manufacturing quality history documentation as required
• Lead initial investigation and disposition decisions for Non-Conforming Material (NCM)
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 Product/Manufacturing/Process Engineers and other SMEs to address customer quality concerns
• Lead CAPA development in response to customer requests, creation of customer defined quality reports, and provide feedback and documentation to the customer as required
Manufacturing Readiness
• Create and maintain all required quality guidance and documentation for manufacturing readiness including internal quality assurance/control 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 applicable quality assurance/control plan to ensure compliance with customer specifications, industry standards, regulatory requirements, and 4FRONT Solutions standards.
• Ensure customer QMS, manufacturing, and quality assurance requirements are included in specifications as/where required
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 manufacturing and quality goals
• Lead analysis of quality metric data and identify opportunities to reduce scrap, rework, and customer returns
• Collaborate with the Product/Manufacturing/Process Engineer to implement improvements
• Lead Corrective and Preventative Action (CAPA) development for repeat or systemic issues and ensure successful implementation
Required Skills:
• Strong analytical, problem solving, critical thinking and innovative solution capabilities
• Handles self with finesse and diplomacy with an understanding of changing priorities, sense of urgency, execution of results and support for the team
• Is an effective, mature, self-aware team player who has a calming style
• Leads and initiates change effectively and is flexible and collaborative in all cross-functional responsibilities
• Operates with high integrity, is productive under high pressure, hands-on when needed
• Demonstrates excellent communication ability using strong listening skills and logical, systematic approach to assimilating and sharing information in all areas
• Displays situational leadership by applying experiences to current/new challenges and situations
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