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 qualit

📌 Quality Specialist II (Monterrey)
🏢 ThermoFisher Scientific
📍 Monterrey