Quality Engineer III [Remote]

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Location: Marietta, OH. Relocation assistance is NOT provided. 

*Must be legally authorized to work in the United States without sponsorship now or in the future.

*Must be able to pass a comprehensive background check, which includes a drug screening.

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Discover Impactful Work:

As a Quality Engineer III, you'll help ensure quality excellence and regulatory compliance across manufacturing operations. You'll help ensure our products meet the highest standards while supporting our mission to enable customers to make the world healthier, cleaner and safer. This role combines technical expertise with quality oversight to maintain robust quality management systems, lead investigations, drive continuous improvement, and ensure GMP/ISO compliance.

A Day in the Life:

• Be the SME within the quality group by being hands on in resolving quality issues, conducting risk assessments and managing CAPAs

• Support audits

• Implement quality initiatives

• Interface and influence stakeholders on quality issues/ updates

• Interface effectively with internal teams and external customers/regulators

• Establish and maintain quality standards

• Support a culture of continuous improvement and compliance

How Will You Get Here?

Education:

• Minimum Education Required: Bachelor's Degree (Preferred Fields of Study: Mechanical or Industrial Engineering or related technical field)

• ASQ certifications (CQE, CQA) desired

Experience:

• Experience Required: 2+ years of experience in quality assurance in regulated industry (pharmaceutical, medical device, or biotech)

• Expertise in quality systems including: CAPA and deviation management, change control, risk management, FMEA, document control and internal/ external auditing

• Experience with validation and qualification protocols

Knowledge, Skills, Abilities :

• Working knowledge of ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)

• Advanced problem-solving and root cause analysis skills

• Excellent project management abilities

• Strong verbal and written communication skills

• Proficiency with quality management software and MS Office

• Knowledge of statistical analysis and quality tools

• Ability to work both independently and collaboratively

• Strong attention to detail while maintaining broad perspective

• Excellent interpersonal skills for cross-functional collaboration

• May require up to 10% travel

• Additional language skills may be beneficial

Benefits

We offer competitive compensation, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 140,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.