Quality Specialist II (Supplier Quality Acceptance)

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 manufacturing, bioprocessing equipment, capital equipment or a comparable engineered product environment.

- Relevant experience includes supplier quality, source inspection, incoming inspection, manufacturing quality, quality acceptance, validation, or comparable quality activities supporting mechanical and/or electrical components, fabricated assemblies, capital equipment, or other engineered products.
- Experience performing quality inspection or acceptance activities against engineering drawings, specifications, inspection plans, or defined acceptance criteria.
- Experience documenting inspection and quality results within controlled quality, ERP, eQMS, or electronic record systems.
- Experience identifying and documenting nonconforming conditions and supporting nonconformance, supplier corrective action, CAPA, or related quality investigation processes.
- Experience reviewing supplier/manufacturing quality documentation and objective evidence.
- Experience using inspection and measurement equipment appropriate to mechanical and/or electrical components and assemblies.
- Experience interpreting engineering drawings, specifications, tolerances, Bills of Materials, and quality requirements.

Preferred:

- Experience working directly with suppliers or fabricators.
- Experience with stainless-steel fabrication, weld inspection, surface finishes, and fabricated equipment.
- Experience with fabricated equipment used in pharmaceutical, biotechnology, bioprocessing, food, cosmetic, medical-device, or other regulated manufacturing environments.
- Experience with FAT, HAT, source inspection, supplier acceptance, or customer-facing project execution.
- Experience with ERP, eQMS, and document-control systems.
- Experience with single-use bioprocessing equipment, vessel hardware, automation systems, or capital equipment.
- Familiarity with sampling plans and acceptance criteria.
- Experience with supplier corrective-action processes.

Knowledge, Skills, Abilities:

- Strong working knowledge of quality inspection, product acceptance, nonconformance, and supplier quality practices.
- Ability to independently evaluate product and documentation conformance against approved drawings, specifications, purchase requirements, inspection plans, and acceptance criteria.
- Ability to make objective, risk-based quality acceptance, rejection, or escalation decisions within established procedures and delegated authority.
- Strong ability to read and interpret mechanical and electrical drawings, specifications, Bills of Materials, inspection plans, dimensional tolerances, GD&T, and quality requirements applicable to supplier acceptance activities.
- Working knowledge of mechanical and electrical inspection techniques applicable to fabricated components, assemblies, equipment, wiring, welds, dimensions, surface finishes, and workmanship.
- Working knowledge of inspection procedures, sampling methods, inspection plans, and acceptance criteria applicable to supplier quality acceptance activities.
- Proficiency using applicable inspection and measurement tools, including tape measures, calipers, micrometers, profilometers, optical tachometers, and other hand or measurement tools required for assigned inspection activities.
- Ability to identify nonconforming conditions, document clear objective evidence, and support containment, disposition, and corrective-action processes.
- Knowledge of quality documentation, traceability, document control, and data-integrity requirements.
- Ability to review supplier certificates, inspection records, material documentation, calibration records, test reports, and other objective evidence for completeness and conformance.
- Ability to support defined quality and acceptance processes during equipment qualification, hardware acceptance, and related supplier activities while maintaining process consistency and quality expectations.
- Strong analytical and problem-solving skills with the ability to identify recurring quality issues, recognize trends, and escalate potential systemic concerns.
- Strong attention to detail and commitment to inspection accuracy, documentation quality, traceability, and consistent application of acceptance requirements.
- Strong written and verbal communication skills with the ability to communicate acceptance status, nonconformances, technical findings, and required actions clearly to suppliers and internal stakeholders.
- Strong cross-functional collaboration skills with the ability to work effectively with Supplier Quality, Engineering, Operations, Procurement, Project Management, and suppliers.
- Ability to manage multiple supplier acceptance activities and priorities independently while meeting project and delivery requirements.
- Ability to work effectively in supplier, manufacturing, fabrication, receiving, and testing environments with minimal supervision.
- Ability to identify nonconforming conditions, document clear objective evidence, and support containment, investigation, root-cause analysis, disposition, supplier corrective action, and CAPA processes as applicable.
- Working knowledge of GMP, quality systems, nonconformance management, supplier corrective action, CAPA, and applicable regulated-manufacturing requirements.
- Proficiency with Microsoft Office and applicable ERP, eQMS, document-control, and quality-record systems.

Physical Requirements and Work Environment:

- Combination of office-based quality work and regular activity within manufacturing, fabrication, receiving, testing, and supplier environments.
- Regular use of computers, laptops, tablets, ERP/eQMS, document-control, and quality systems for extended periods.
- Frequent standing and walking while performing inspection, acceptance, and supplier-quality activities.
- May require bending, kneeling, reaching, crouching, climbing ladders, or accessing equipment at floor level to inspect components, assemblies, vessels, electrical equipment, or other products.
- Manual dexterity required to safely handle and operate inspection and measurement tools and equipment.
- Required use of appropriate PPE when entering designated manufacturing, fabrication, testing, receiving, or supplier work areas.
- Exposure to manufacturing/fabrication equipment, metalworking environments, electrical equipment, and moderate noise levels as applicable to the work environment.
- Ability to lift and carry inspection equipment, tools, materials, or components up to 35 lbs.
- Requires up to 50% travel by air and ground transportation to supplier and other business locations throughout North America.
- May require schedule flexibility to support supplier acceptance activities, FAT/HAT schedules, project requirements, travel, or other business-critical quality activities.