Quality Engineer III

Regulatory Jobs; St. Louis (MO); On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Quality Engineer III to support quality assurance across clinical and commercial manufacturing programs. The role collaborates with cross-functional teams to ensure products meet regulatory requirements and quality standards.

This individual contributor position emphasizes investigation of quality events, process improvements, and support for technology transfer and regulatory inspections.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or another scientific or technical discipline.

Responsibilities

• Support QA activities for clinical and commercial manufacturing programs.
• Partner with Manufacturing, Operations, Engineering, Validation, Regulatory Affairs, and other teams to ensure GMP compliance.
• Review and approve GMP documentation including batch records, deviations, CAPAs, and validation documents.
• Lead quality investigations, perform root cause analyses, and support corrective and preventive actions.

Skills

Quality assurance

Regulatory compliance

Root cause analysis

Statistical analysis

Project management

Communication

Education

Bachelor's degree in engineering, life sciences, chemistry or related field

Advanced degree (preferred)

Tools

Quality Management System (QMS)

Microsoft Office

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

How Will You Make an Impact?

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day to enable our customers to make the world healthier, cleaner, and safer.

As a Quality Engineer III within the Product Quality organization, you will play a key role in supporting quality assurance activities for clinical and commercial manufacturing programs. In this individual contributor role, you will partner with cross-functional teams to ensure products are manufactured in compliance with applicable regulatory requirements while supporting operational excellence and continuous improvement initiatives.

You will apply your technical expertise to investigate quality events, support quality systems, identify process improvements, and help ensure products consistently meet customer and regulatory expectations. Your contributions will directly support Thermo Fisher Scientific's commitment to delivering high-quality products and enabling customer success.

Key Responsibilities

• Support quality assurance activities for clinical and commercial manufacturing programs.
• Partner with Manufacturing, Operations, Engineering, Validation, Regulatory Affairs, and other functional teams to ensure compliance with GMP and regulatory requirements.
• Review and approve GMP documentation, including batch records, deviations, change controls, CAPAs, and validation documentation.
• Lead quality investigations, perform root cause analyses, and support the implementation of effective corrective and preventive actions.
• Evaluate quality system data and metrics to identify trends and recommend process improvements.
• Participate in risk assessments and quality planning activities to support product lifecycle management.
• Support technology transfer activities and implementation of new manufacturing processes.
• Participate in internal audits, customer audits, and regulatory inspections.
• Contribute to continuous improvement initiatives that strengthen quality systems and operational performance.
• Maintain current training requirements and ensure compliance with company policies, GMP regulations, and applicable quality standards.
• Perform other duties as assigned.

Minimum Qualifications

Education

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or another scientific or technical discipline.

Experience

• Advanced degree with 3+ years of experience, or bachelor's degree with 5+ years of experience in quality assurance within a regulated pharmaceutical, biotechnology, medical device, or related manufacturing environment.
• Demonstrated experience supporting GMP quality systems and regulatory compliance.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant quality certification.
• Experience supporting biologics manufacturing or biopharmaceutical processes.
• Experience with technology transfer and process validation.
• Experience supporting customer audits and regulatory inspections.
• Experience applying statistical analysis and quality metrics to drive continuous improvement.

Knowledge, Skills, and Abilities

• Working knowledge of FDA, EMA, ICH, GMP, and applicable regulatory requirements.
• Experience with deviation investigations, CAPA management, change control, quality risk management, and document control.
• Knowledge of validation and qualification activities.
• Strong analytical and root cause problem-solving skills.
• Effective project management and organizational skills.
• Excellent written and verbal communication skills.
• Ability to collaborate effectively across multiple functional teams.
• Ability to prioritize multiple assignments in a fast-paced environment.
• Proficiency with Microsoft Office applications and quality management systems.
• Strong attention to detail and commitment to quality.

Competencies

Successful candidates will demonstrate:

• Customer focus
• Collaboration and teamwork
• Quality and compliance mindset
• Accountability and ownership
• Continuous improvement orientation
• Technical problem solving
• Effective communication
• Sound judgment

Work Environment

This position operates in a regulated GMP manufacturing environment and may require interaction with production, laboratory, warehouse, and office-based functions. Occasional travel (up to 25%) may be required.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Other

Relocation assistance is not provided.

Must be legally authorized to work in the United States now and in the future, without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.