Quality Specialist II (Supplier Quality Acceptance)

Job description

Work Schedule First Shift (Days) Environmental Conditions Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description How You Will Make an Impact: The Quality Specialist II – Supplier Quality Acceptance supports product quality and supplier performance by independently performing supplier quality acceptance activities for materials, components, fabricated assemblies, and equipment used in single-use bioprocessing and automation systems. This role evaluates product and documentation conformance against approved drawings, specifications, purchase requirements, inspection plans, and quality standards; identifies and documents nonconforming conditions; and supports timely resolution of supplier quality issues. The position applies sound quality judgment, objective evidence, and risk-based decision making while collaborating with Supplier Quality, Engineering, Operations, Procurement, Project Management, and suppliers to. ensure compliant and timely product acceptance, protect manufacturing and customer commitments, and drive continuous improvement in supplier quality performance. This role requires up to 50% travel to supplier and other business locations that includes Mexico, North America to perform supplier quality acceptance, source inspection, FAT/HAT/vHAT, and related quality activities. Day In The Life: Independently perform supplier quality acceptance activities at supplier sites, receiving locations, and other designated locations using approved engineering drawings, specifications, purchase requirements, inspection plans, quality requirements, and defined acceptance criteria. Inspect mechanical and electrical components, fabricated assemblies, and equipment, including stainless-steel vessels, fabricated hardware, electrical enclosures, controllers, wiring, welds, surface finishes, dimensions, workmanship, and other defined product characteristics. Select and use appropriate inspection and measurement equipment and methods to verify dimensions, mechanical and electrical characteristics, surface finish, weld quality, electrical connections, workmanship, and other defined product characteristics and acceptance requirements. Review and interpret engineering drawings, specifications, Bills of Materials (BOMs), tolerances/GD&T, quality requirements, and acceptance criteria to determine applicable inspection and acceptance requirements and identify gaps or ambiguities requiring clarification. Review supplier work and manufacturing progress against approved drawings, specifications, quality requirements, and acceptance criteria and identify conditions that may affect product quality, acceptance readiness, project schedules, or delivery. Perform or support source inspection, receiving acceptance, in-process verification, Factory Acceptance Testing (FAT), Hardware Acceptance Testing (HAT and virtual HAT), validation, and related quality acceptance activities to verify conformance and acceptance readiness prior to shipment, receipt, handover, or release. Review supplier quality documentation and objective evidence required for acceptance, including certificates, inspection records, material documentation, calibration records, test reports, and other applicable quality records for completeness, accuracy, traceability, and conformance to defined requirements. Document inspection results, acceptance status, discrepancies, and supporting objective evidence in inspection reports, logs, ERP/eQMS records, and other required systems, ensuring records are accurate, complete, timely, and traceable. Make objective acceptance, rejection, or escalation decisions within established procedures and delegated authority based on documented requirements, inspection results, objective evidence, and product or quality risk. Identify and document nonconforming conditions when supplier products, processes, documentation, or records do not meet defined requirements. Escalate significant, recurring, high-risk, or potentially systemic supplier quality issues to Supplier Quality and Quality leadership as appropriate. Collaborate with Supplier Quality, Engineering, Operations, Procurement, Project Management, Quality, and suppliers to clarify technical and quality requirements, resolve acceptance issues, and support timely product disposition and acceptance. Clearly communicate acceptance status, discrepancies, nonconformances, deviations, required follow-up, and unresolved quality concerns to suppliers and appropriate internal stakeholders. Provide inspection findings, objective evidence, and technical quality input to support supplier quality reviews, issue resolution, risk assessment, and quality-related project decisions. Maintain professional and effective supplier communication while supporting practical, compliant, and timely resolution of quality issues. Support disposition activities by providing objective inspection evidence and clearly identifying the applicable requirement that was not met. Initiate or support nonconformance, supplier corrective action, and Corrective and Preventive Action (CAPA) activities, as applicable, including containment, objective-evidence collection, investigation and root-cause analysis support, follow-up, and verification of completed corrective and preventive actions. Support supplier/fabricator readiness by communicating inspection expectations, acceptance requirements, documentation needs, and identified quality concerns prior to or during acceptance activities. Track recurring inspection findings, nonconformance trends, and supplier defects and provide quality data and observations to support supplier performance monitoring and improvement activities. Identify and recommend improvements to inspection methods, acceptance criteria, checklists, work instructions, documentation practices, and quality records based on lessons learned and recurring issues. Support implementation and consistent application of standardized inspection methods, acceptance criteria, and documentation practices across supplier quality acceptance activities. Participate in Practical Process Improvement (PPI) and continuous improvement initiatives focused on supplier quality, inspection effectiveness, defect reduction, process consistency, and acceptance cycle time. Perform supplier quality acceptance activities in accordance with applicable quality-system, GMP, data-integrity, documentation, environmental, health, safety, and regulatory requirements. Follow applicable Thermo Fisher Scientific and supplier-site safety requirements and use required PPE and safe work practices while working in manufacturing, fabrication, receiving, testing, and supplier environments. Maintain complete, accurate, attributable, and traceable quality records in accordance with applicable documentation and data-integrity requirements. Perform other duties as assigned to support evolving BEA business needs. The responsibilities described above are representative of the nature and level of work performed and are not intended to be an exhaustive list of all duties and responsibilities. Education & Experience: Required: Advanced Degree in Engineering, Quality, Life Sciences, Manufacturing or a related technical field; OR Bachelor's Degree in Engineering, Quality, Life Sciences, Manufacturing or a related technical field with 2 years of relevant experience in regulated manufacturing, bioprocessing equipment, capital equipment or a comparable engineered product environment; OR Associate Degree in an engineering or related technical discipline with 4 years of relevant experience in regulated manufacturing, bioprocessing equipment, capital equipment or a comparable engineered product environment; OR High School Diploma or equivalent with 6 years of experience in regulated