Engineer III - Quality Systems And Documentation

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:

We are seeking an Engineer III - Quality Systems & Documentation to lead quality documentation standardization, supplier quality governance, and Bill of Quality (BOQ) readiness across the global Contract Manufacturing network.

This role will partner with Quality, Manufacturing Engineering, Regulatory, Procurement, Operations, and external manufacturing partners to establish consistent quality documentation frameworks, improve audit readiness, support technology transfers, and strengthen supplier quality performance through disciplined documentation and governance.

Key Responsibilities

• Develop and deploy quality documentation frameworks, templates, standards, and governance routines across Contract Manufacturing partners
• Support Bill of Quality (BOQ) framework development including quality requirements, inspection controls, validation evidence, risk controls, and supplier documentation expectations
• Define and maintain supplier quality documentation requirements for technology transfers, product changes, new supplier onboarding, and ongoing production support
• Partner with Quality and Operations teams to ensure documentation aligns with applicable quality management systems, regulatory expectations, and internal standards
• Support audit readiness by ensuring controlled documents, evidence packages, change records, and supplier quality files are accurate, complete, and retrievable
• Review and improve supplier quality documentation including control plans, inspection plans, validation records, nonconformance data, CAPA evidence, and risk documentation
• Support quality risk assessments, process FMEAs, control strategy development, and issue resolution related to external manufacturing operations
• Lead continuous improvement initiatives to reduce documentation defects, improve right-first-time quality, and strengthen supplier governance
• Contribute to technology transfer readiness reviews by evaluating quality documentation completeness, inspection readiness, and process control maturity
• Maintain quality best-practice libraries, quality playbooks, lessons learned, and reusable templates for global deployment
• Partner with digital and documentation teams to improve quality record structure, searchability, version control, and lifecycle governance
  
  

• Bachelor's degree with 8+ years of experience or Master's degree with 6+ years of experience in Quality Engineering, Manufacturing Engineering, Life Sciences, Industrial Engineering, or a related technical discipline
• Experience in quality systems, supplier quality, manufacturing quality, documentation control, or regulated manufacturing operations
  
  

• Experience supporting Contract Manufacturers, OEMs, supplier quality management, or external manufacturing operations
• Knowledge of ISO 13485, FDA Quality System Regulation, ISO 9001, GMP, risk management, CAPA, audit readiness, and change control processes
• Experience developing quality documentation standards, quality plans, inspection requirements, and supplier quality records
• Working knowledge of process validation, verification, FMEA, control plans, nonconformance management, and corrective action systems
• Experience supporting regulated industries such as Medical Device, Life Sciences, Diagnostics, Pharma, Analytical Instruments, or Aerospace
• Familiarity with PLM, ERP, eQMS, document management systems, SharePoint, or quality records platforms
• Strong ability to interpret quality requirements and convert them into practical documentation and governance processes
• Strong analytical, communication, and stakeholder management skills in a global matrix environment
• Certification such as ASQ CQE, CQA, Six Sigma Green Belt, or Lead Auditor preferred
  
  

• Quality systems thinking with strong compliance discipline
• Supplier quality governance and documentation excellence
• Risk-based decision-making and structured problem solving
• Audit readiness and attention to detail
• Cross-functional collaboration and influence
• Continuous improvement orientation
• Strong ownership of quality outcomes and customer impact