Quality Engineer III
@ Thermo Fisher Scientific

Frederick County, Virginia, United States
On Site
Full Time
Posted 4 days ago

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XXXXXXXXX XXXXXXXXXXXXX XXXXXXXXX****** @thermofisher.com
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Job Details

About Thermo Fisher Scientific

At Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way for the right reasons, with the customer always top of mind. Our work matters in finding cures for cancer, protecting the environment, ensuring food safety, and delivering COVID-19 solutions.

Location & Division

Join our dynamic team in the United States, where excellence and innovation in engineering are prioritized.

Job Responsibilities

  • Facilitate risk management activities in compliance with ISO 14971:2019
  • Maintain up-to-date risk management files
  • Review and approve process and product validations (TMV/IQ/OQ/PQ)
  • Ensure compliance with the Quality Management System
  • Collaborate across functions to meet customer needs
  • Review and approve CAPA action plans and complete CAPA effectiveness checks
  • Collaborate in resolving non-conformances and make product disposition decisions
  • Participate in quality improvement initiatives
  • Represent the quality function in customer facing meetings
  • Support internal and external audits

Qualifications

  • BS in Biomedical Engineering, Industrial Engineering, Chemistry or related field
  • At least three years of experience in a similar Quality Engineer role in the medical device or pharmaceutical industry
  • Direct experience with ISO 13485:2016 and 21 CFR 820
  • Knowledge of Quality Management Systems, continuous improvement methodologies, and risk management
  • Demonstrated skills in prioritizing conflicting demands and strong analytical/problem solving capabilities
  • Excellent interpersonal, organizational, written, and presentation skills
  • Proficient with Microsoft tools and MiniTab
  • ASQ certification is desired
  • Experience with ISO 14971:2019 and EU Regulation 2017/746 preferable
  • Proficiency in statistical analysis techniques is a plus

Physical Requirements & Work Environment

This position may require long periods of standing and may be performed in a lab or manufacturing environment.

Benefits & Culture

Enjoy competitive remuneration, annual incentive plan bonus, healthcare and a range of employee benefits. Work in an innovative, forward-thinking organization with outstanding career and development prospects.

Key Skills/Competency

Quality Management, Risk Management, ISO Standards, CAPA, Validation, Non-conformance, Continuous Improvement, Statistical Analysis, Team Collaboration, Audit Support

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How to Get Hired at Thermo Fisher Scientific

🎯 Tips for Getting Hired

  • Customize your resume: Highlight ISO, risk, and quality expertise.
  • Prepare for technical questions: Review ISO standards and validation processes.
  • Showcase teamwork: Emphasize collaborative project experiences.
  • Research Thermo Fisher Scientific: Understand their culture and recent innovations.

📝 Interview Preparation Advice

Technical Preparation

Review ISO 13485 and ISO 14971 standards.
Practice CAPA and risk management scenarios.
Brush up on statistical analysis techniques.
Familiarize with validation documentation methods.

Behavioral Questions

Describe a team conflict resolution experience.
Explain a time you prioritized conflicting demands.
Discuss a challenge in quality compliance.
Share how you adapt to fast-paced changes.

Frequently Asked Questions