Quality Engineer III

Thermo Fisher Scientific•St. Louis, MO

9d•Onsite

About The Position

As a Quality Engineer III within Thermo Fisher Scientific’s Product Quality organization, you will support 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. You will apply technical expertise to investigate quality events, support quality systems, identify process improvements, and help ensure products consistently meet customer and regulatory expectations. The role operates in a regulated GMP manufacturing environment and may involve interaction with production, laboratory, warehouse, and office-based functions. Occasional travel of up to 25% may be required.

Requirements

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

Nice To Haves

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.

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 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.