Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Quality Engineer III

Location: Marietta, OH (Relocation assistance is not available for this position.)

Work Authorization: Applicants must be legally authorized to work in the United States without current or future sponsorship.

Pre-Employment Requirements: Candidates must successfully complete a comprehensive background check, including a drug screening.

Make an Impact Every Day

At Thermo Fisher Scientific, your work has a purpose. Every day, our teams help customers advance life-changing research, improve patient outcomes, and create a healthier, cleaner, and safer world.

As a global leader with more than $40 billion in annual revenue and one of the industry's largest investments in research and development, we provide our employees with the tools, resources, and opportunities to build meaningful careers. If you're looking for a collaborative environment where your expertise is valued and your ideas drive continuous improvement, we'd love to hear from you.

Discover Impactful Work

We're seeking a Quality Engineer III to join our Marietta, Ohio team. In this role, you'll serve as a key quality expert supporting manufacturing operations, ensuring products consistently meet the highest quality and regulatory standards.

You'll collaborate with cross-functional teams to strengthen quality systems, solve complex challenges, lead continuous improvement initiatives, and help maintain compliance with FDA, ISO, and GMP requirements. Your work will directly support products that improve lives around the world.

What You'll Do

As a Quality Engineer III, you will:

• Serve as a subject matter expert (SME) for quality systems and manufacturing quality support.

• Lead investigations into quality events using structured root cause analysis techniques.

• Drive corrective and preventive actions (CAPAs) through implementation and effectiveness verification.

• Conduct risk assessments and support FMEA activities to proactively reduce risk.

• Support internal, customer, and regulatory audits while helping maintain inspection readiness.

• Partner with Manufacturing, Engineering, Operations, and Regulatory teams to resolve quality issues and implement sustainable improvements.

• Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards.

• Develop, review, and improve quality documentation, procedures, and processes.

• Monitor quality performance metrics and identify opportunities to improve efficiency, compliance, and product quality.

• Champion a culture of quality, accountability, and continuous improvement throughout the organization.

What You'll Bring

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, or another technical or engineering discipline.

• Minimum of 2 years of quality engineering or quality assurance experience within a regulated industry such as medical device, pharmaceutical, biotechnology, or a similar manufacturing environment.

• Experience supporting Quality Management Systems (QMS), including:

  • CAPA

  • Deviation management

  • Change control

  • Risk management

  • Internal and external audits

  • Document control

• Experience supporting equipment, process, or product validation and qualification activities.

Preferred Qualifications

• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant quality certification.

• Experience working in FDA-regulated and ISO-certified environments.

Knowledge, Skills & Abilities

Successful candidates will demonstrate:

• Working knowledge of ISO 13485, ISO 9001, FDA Quality System Regulations, GMP, and other applicable regulatory requirements.

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