ClinLab Solutions Group

FAIR Quality Engineer (3 month contract)

Posted: 2 hours ago

Job Description

PLEASE NO C2C!Job PurposeAs a Staff Quality Control Engineer, your mission is to ensure Quality Control processes comply with regulatory and customer requirements while driving operational excellence across manufacturing operations. You will collaborate with Manufacturing, Logistics, Sales, and Engineering to build accurate data and metrics that improve lead-time predictability. By leading product disposition and corrective actions, you will strengthen customer trust, reduce variation, and empower teams to resolve quality issues effectively.Key ResponsibilitiesLead inspection and testing of materials, equipment, processes, and products to meet quality specifications.Implement Quality Control processes that meet regulatory and customer requirements.Develop and drive measurable quality improvements relating to products and processes.Create and validate test and inspection methods, ensuring repeatability and compliance.Assure the QMS conforms to customer, internal, industry (AS9100, ISO 9001, ISO 13485), and regulatory/legal requirements.Collaborate across Manufacturing, Logistics, Sales, and Engineering to develop reliable data and metrics that enable accurate lead times.Lead the disposition of production material and corrective actions of nonconforming product to ensure compliance, throughput, and customer satisfaction.Engage and support shop floor personnel and manufacturing defect prevention teams, using data to drive resolution, containment, and corrective action within closed-loop controls.Perform process walks, operator observations, and lead manufacturing team discussions to reduce variation and drive process enhancements.Lead Advanced Product Quality Planning (APQP) initiatives (PFMEA, Control Plans, SPC, etc.) to prevent defects and ensure verification/validation of improvements.Integrate product and process verifications such as First Articles and audits throughout the value stream to prevent quality escapes and ensure on-time delivery.QualificationsBachelor’s degree in Engineering, Quality, or a related field preferred; equivalent hands-on experience will also be considered.7+ years of Quality Engineering or Quality Control experience in manufacturing, aerospace, defense, or medical devices.Strong knowledge of Root Cause Analysis, data analysis, and Statistical Process Control (SPC).Experience with First Article Inspection Reports (FAIRs), quality monitoring, and leading corrective actions across cross-functional teams.Familiarity with APQP/AS9145 tools such as PPAP, DFMEA, PFMEA, and Control Plans.Proficiency in interpreting engineering drawings, BOMs, work instructions, and GD&T.Hands-on experience with quality systems and compliance standards (ISO 9001, AS9100, ISO 13485).Excellent communication skills with the ability to collaborate across shop floor and leadership levels.

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