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Staff QA Engineer

Thermo Fisher Scientific Inc

Greenville, NC

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JOB DETAILS
SKILLS
American Society for Quality (ASQ), Analysis Skills, Auditing, Biology, Biotech and Pharmaceutical, Cancer, Certified Quality Engineer (CQE), Change Control, Chemistry, Communication Skills, Computer Systems, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Data Quality, Detail Oriented, Document Control, Document Management, External Audit, FDA Requirements, Failure Mode and Effects Analysis (FMEA), Food Safety, GMP (Good Manufacturing Practices), ISO 9001, Insurance Regulations, Internal Audit, Medical Equipment, Presentation/Verbal Skills, Problem Solving Skills, Process Validation, Project/Program Management, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Risk Management, Root Cause Analysis, SAP, Statistics, System Validation, Team Lead/Manager, Team Player, Technical Writing, Willing to Travel, Writing Skills
LOCATION
Greenville, NC
POSTED
5 days ago

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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.

Join our collaborative team at Thermo Fisher Scientific as a Staff QA Engineer, where you'll contribute to ensuring product quality and regulatory compliance across our operations. You'll work at the intersection of quality assurance, regulatory compliance, and continuous improvement to help deliver life-changing solutions to our customers. Collaborate with cross-functional teams to advance quality initiatives, conduct audits, manage validation activities, and support a culture of excellence. Your expertise will directly impact our mission of enabling customers to make the world healthier, cleaner, and safer through innovative scientific solutions.

REQUIREMENTS:

  • Strong knowledge of GMP regulations, ISO standards (9001, 13485), and regulatory requirements (FDA, EMA, etc.)
  • Experience conducting internal and external audits, including regulatory inspections and client audits
  • Expertise in quality systems including CAPA, change control, document control, and risk management
  • Proficiency in quality tools and methodologies (FMEA, root cause analysis, statistical analysis)
  • Experience with validation activities (IQ/OQ/PQ, process validation, computer system validation)
  • Strong project management and cross-functional team leadership abilities
  • Advanced problem-solving and analytical skills with attention to detail
  • Excellent written and verbal communication skills
  • Experience with quality management software systems (TrackWise, SAP, etc.)
  • Knowledge of data integrity requirements and computer system compliance
  • Ability to review and approve technical documentation, protocols, and reports
  • Experience supporting quality professionals
  • Travel up to 25% as required

Education:

  • Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of quality assurance experience in regulated environments (pharmaceutical, medical device, or biotech industry)
  • Preferred Fields of Study: Engineering, Life Sciences, Chemistry, Biology, or related technical/scientific field
  • Additional certifications preferred: ASQ CQE (Certified Quality Engineer), CQA (Certified Quality Auditor), or relevant industry certifications

About the Company

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Thermo Fisher Scientific Inc

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of nearly $11 billion, we have approximately 37,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through two premier brands, Thermo Scientific and Fisher Scientific, which offer a unique combination of continuous technology development and the most convenient purchasing options. Our products and services help accelerate the pace of scientific discovery, and solve analytical challenges ranging from complex research to routine testing to field applications.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

If you share in our values and if you're looking for an employer who is strongly committed to developing talent and rewarding achievement, come grow with us at Thermo Fisher Scientific.

Thermo Fisher Scientific is an Equal Employment Opportunity and Affirmative Action employer.

COMPANY SIZE
10,000 employees or more
INDUSTRY
All
WEBSITE
https://corporate.thermofisher.com/en/home.html