About the role

Aplyr's Quick Take

This role is focused on ensuring product quality and regulatory compliance in a manufacturing environment, specifically in calibration and metrology. You'll be involved in quality oversight, investigations, and continuous improvement initiatives, working closely with various teams. It's an individual contributor role requiring technical expertise and strong communication skills.

Good fit

Ideal candidates have a background in quality assurance within regulated industries like pharmaceuticals or biotech, with at least 3-5 years of experience. Those who thrive here are analytical, detail-oriented, and comfortable collaborating across teams.

Worth noting

The position emphasizes compliance with stringent GMP and ISO standards, which may be a red flag for those not familiar with regulatory environments. The role also requires advanced problem-solving skills and experience with quality systems.

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
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.

You'll work with multiple teams to resolve quality issues, conduct validation and equipment-based risk assessments, manage CAPAs, support audits, and implement quality initiatives. The role requires strong analytical and communication skills to interface effectively with internal teams and external customers/regulators. You'll help establish and maintain quality standards while supporting a culture of continuous improvement and compliance.

REQUIREMENTS:
• Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance in regulated industry (pharmaceutical, medical device, or biotech)
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field
• ASQ certifications (CQE, CQA) desired
• Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)
• Expertise in quality systems including:

• Quality oversight of Calibrations and Metrology

• SAP knowledge a plus
• CAPA and deviation management
• Change control
• Risk management and FMEA
• Document control
• Internal/external auditing
• 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
• Experience with validation and qualification protocols
• 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 25% travel
• Additional language skills may be beneficial

Benefits

We offer competitive remuneration, 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!

Other

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.

Aplyr's read

Thermo Fisher Scientific is a powerhouse in biotechnology, attracting professionals passionate about advancing scientific research and innovation across diverse roles and regions.
Synthesized from recent postings & public sources

What's promising

•Thermo Fisher is a leader in the biotech industry, offering stability and growth potential.
•The company invests heavily in R&D, fostering innovation and cutting-edge solutions.
•Global presence provides diverse career opportunities across multiple regions and disciplines.

What to watch

•High pressure and fast-paced environment may not suit everyone.
•Complex organizational structure can lead to communication challenges.
•Frequent acquisitions may result in uncertainty and change for employees.

Why Thermo Fisher

•Thermo Fisher's broad product portfolio spans laboratory equipment to clinical diagnostics.
•The company plays a crucial role in global scientific advancements and healthcare solutions.
•Strong focus on sustainability and corporate responsibility sets it apart in the industry.

Aplyr’s read is generated by AI from public sources. Was it useful?

About Thermo Fisher

Thermo Fisher

thermofisher.com

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Thermo Fisher Scientific is a global leader in serving science, providing a range of products and services to help researchers and scientists in laboratories and clinical settings.