Quality Engineer III - Quality of the Floor

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

Quality Engineer III - Quality on the Floor

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our team in bringing our Mission to life every day: enabling our customers to make the world healthier, cleaner and safer.

Our colleagues are empowered with the resources, support, and opportunities they need to grow their careers while helping solve some of the world’s toughest challenges — from protecting the environment and ensuring food safety to advancing life-saving treatments and finding cures for cancer.

About the Role

We are looking for a Quality on the Floor to join our team and play a key role in driving quality excellence and regulatory compliance across manufacturing operations. In this position, you will help ensure our products meet the highest standards of quality while supporting systems and processes that align with GMP and ISO requirements.

This is an exciting opportunity for a quality professional who enjoys combining technical expertise with collaborative problem-solving to strengthen quality systems, support investigations, and champion continuous improvement initiatives.

What You’ll Do

As a Quality on the Floor you will:

• Support and maintain robust quality management systems across manufacturing operations
• Lead and support investigations related to quality issues, deviations, and non-conformances
• Drive CAPA activities and ensure effective implementation of corrective and preventive actions
• Conduct risk assessments and apply tools such as FMEA to support decision-making
• Partner cross-functionally with manufacturing, engineering, regulatory, and other teams to resolve quality challenges
• Support internal and external audits, including interactions with customers and regulatory agencies
• Help ensure compliance with cGMP, ISO 13485/9001, and other applicable regulatory requirements
• Contribute to validation and qualification activities
• Identify opportunities for process improvements and help foster a culture of quality and continuous improvement

What We’re Looking For

We are seeking a motivated and detail-oriented professional with a strong background in quality assurance within a regulated industry such as pharmaceutical, medical device, or biotech.

Minimum Qualifications:

• Advanced degree with 3+ years of experience, or Bachelor’s degree with 5+ years of experience in quality assurance in a regulated industry
• Degree in Engineering, Life Sciences, Chemistry, or a related technical field preferred
• Strong knowledge of cGMP and applicable regulatory requirements such as FDA and EMA standards
• Experience with core quality systems, including:
  • CAPA and deviation management
  • Change control
  • Risk management and FMEA
  • Document control
  • Internal and external auditing
• Strong root cause analysis and problem-solving skills
• Strong written and verbal communication skills
• Experience supporting validation and qualification protocols
• Knowledge of statistical analysis and quality tools
• Ability to work independently and collaboratively in a cross-functional environment
• Strong attention to detail with the ability to maintain a broad, strategic perspective
• Willingness to travel up to 10%

Why Join Thermo Fisher Scientific?

When you join us, you become part of a global team dedicated to making a real-world difference. You’ll have the opportunity to grow professionally, contribute to meaningful work, and be part of a company that values innovation, collaboration, and quality in everything we do.

Apply today and help us take science a step beyond.