Quality Engineer III

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

Job summary

Thermo Fisher Scientific in the United States is seeking a Quality Engineer III to support quality assurance for clinical and commercial manufacturing programs. You will partner with cross-functional teams to ensure products meet regulatory requirements and quality standards.

You will review GMP documentation, lead investigations, implement CAPAs, and drive continuous improvement across manufacturing, validation, and regulatory affairs.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical discipline.
• Advanced degree with 3+ years of experience, or bachelor's with 5+ years in quality assurance within a regulated pharmaceutical/biotech/medical device manufacturing environment.
• Experience supporting GMP quality systems and regulatory compliance.

Responsibilities

• Support quality assurance 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 (batch records, deviations, change controls, CAPAs, validation).
• Lead quality investigations and perform root cause analyses; implement CAPAs.
• Evaluate quality system data to identify trends and drive improvements.
• Participate in risk assessments and quality planning for lifecycle management.
• Support technology transfer and new manufacturing processes.
• Participate in internal/customer/regulatory audits and inspections.
• Contribute to continuous improvement of quality systems and operations.
• Maintain training requirements and ensure GMP compliance.

Skills

Quality Assurance

GMP Compliance

CAPA Management

Deviation Investigations

Regulatory Knowledge

Root Cause Analysis

Data Analysis

Project Management

Communication Skills

Attention to Detail

Education

Bachelor's degree in Engineering/Life Sciences

Tools

QMS Software

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.