Quality Engineer III

Schedule

Standard (Mon‑Fri)

Work Environment

Office setting within a regulated GMP manufacturing environment. Interaction with production, laboratory, warehouse, and office‑based functions. Occasional travel (up to 25%) may be required.

How You’ll Make an Impact

As a Quality Engineer III within the Product Quality organization, you will support quality assurance activities for clinical and commercial manufacturing programs, partner with cross‑functional teams to ensure regulatory compliance, and drive continuous improvement initiatives.

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

• 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.

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

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

Benefits

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

Other Information

• 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.