Quality Engineer Position Available In Volusia, Florida

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