Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Position: Filtration Sr. Quality Engineer

Location: Columbia, MO
Schedule: Typical M-F Days, some occasional weekend work

Division / Site Specific Information

This role supports manufacturing operations within Thermo Fisher Scientific, partnering cross-functionally with Operations, Engineering, Regulatory, and Supply Chain teams to ensure quality excellence and regulatory compliance across the site.

Discover Impactful Work

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—enabling our customers to make the world healthier, cleaner, and safer.

As a Quality Engineer III, you will play a critical role in ensuring our products meet the highest quality and regulatory standards. You’ll combine technical expertise with quality leadership to support robust quality systems, drive continuous improvement, and ensure compliance with GMP and ISO requirements while supporting solutions for some of the world’s toughest challenges.

A Day in the Life

Ensure compliance with current Good Manufacturing Practices (cGMPs), ISO 13485/9001 standards, and applicable global regulatory requirements (FDA, EMA, etc.)Lead and support quality system activities including CAPA, deviation management, change control, and document controlConduct root cause analysis, risk assessments, and FMEA to identify and mitigate quality risksSupport internal and external audits, inspections, and customer interactionsPartner cross-functionally to resolve quality issues and drive continuous improvement initiativesSupport validation and qualification activities as requiredAnalyze quality data using statistical tools to identify trends and improvement opportunitiesMaintain accurate quality documentation and ensure timely completion of quality records

Keys to Success

Education

Advanced Degree with a minimum of 3 years of experience ORBachelor’s Degree with a minimum of 5 years of experiencePreferred fields of study: Engineering, Life Sciences, Chemistry, or related technical discipline

Experience

Experience in quality assurance within a regulated industry (pharmaceutical, medical device, or biotechnology)Hands-on experience with quality systems including CAPA, deviations, change control, risk management, and document controlExperience supporting or leading internal and external auditsExperience with validation and qualification protocolsExperience working cross-functionally in a manufacturing environment

Knowledge

Strong understanding of cGMPs, ISO 13485/9001, and global regulatory requirementsKnowledge of statistical analysis methods and quality tools

Skills

Advanced problem-solving and root cause analysis skillsStrong project management capabilitiesProficiency with quality management systems and Microsoft OfficeExcellent verbal and written communication skills

Abilities

Ability to work independently and collaboratively in a fast-paced environmentStrong attention to detail while maintaining a broad quality perspectiveAbility to effectively interface with internal teams, customers, and regulatory agenciesUp to 25% travel may be requiredAdditional language skills are a plus

Other

Must be legally authorized to work in the United States without sponsorship, now or in the futureMust be able to pass a comprehensive background check, including a drug screening