Staff QA Engineer

ThermoFisher Scientific; Greenville (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific is seeking a Staff QA Engineer to join our team in North Carolina. You will help ensure product quality and regulatory compliance across operations, collaborating with cross-functional teams to advance quality initiatives and support audits, CAPA, and validation activities.

The role emphasizes leadership, rigorous quality systems, and data integrity to enable customers to access safe, effective solutions globally.

Qualifications

• Strong knowledge of GMP and ISO standards in regulated environments.
• Experience conducting internal and external audits including regulatory inspections.
• Expertise in CAPA, change control, document control, and risk management.
• Proficiency in quality tools (FMEA, RCA, statistical analysis).
• Experience with IQ/OQ/PQ and process validation.
• Travel up to 25%.
• Excellent written and verbal communication.

Responsibilities

• Lead quality assurance activities across regulatory compliance initiatives.
• Coordinate internal/external audits and regulatory inspections.
• Support validation activities (IQ/OQ/PQ) and process validation.
• Mentor cross-functional teams to uphold a culture of quality.

Skills

GMP knowledge

ISO 9001/13485 knowledge

Regulatory inspections experience

CAPA & Change control

FMEA & RCA

Process validation

Cross-functional leadership

Data integrity awareness

Document control

Audits experience

Quality management software

Education

Advanced Degree + 6 years QA exp in regulated environments

Bachelor's Degree + 8 years QA exp

ASQ CQE

ASQ CQA

Tools

TrackWise

SAP

Job description

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.