Quality Engineer III

Thermo Fisher Scientific•Marietta, OH

2d•Onsite

About The Position

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.

Requirements

Associate'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.
Working knowledge of ISO 13485, ISO 9001, FDA Quality System Regulations, GMP, and other applicable regulatory requirements.
Strong analytical and problem-solving skills with experience using structured root cause analysis methodologies.
Knowledge of statistical methods and quality improvement tools.
Excellent project management and organizational skills with the ability to manage multiple priorities.
Strong verbal and written communication skills with the ability to influence cross-functional teams.
Proficiency with Microsoft Office and quality management software.
Ability to work independently while thriving in a collaborative team environment.
Exceptional attention to detail with a continuous improvement mindset.

Nice To Haves

ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant quality certification.
Experience working in FDA-regulated and ISO-certified environments.

Responsibilities

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.