Role at a glance
- Salary
- Not Disclosed
- Location
- Greenville, North Carolina, United States
- Work arrangement
- On-site
- Employment
- Full-time
- Experience
- 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)
- Education
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of quality assurance experience in regulated environments...
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Role Summary
The Staff QA Engineer contributes to product quality, regulatory compliance, and continuous improvement. The role collaborates with cross-functional teams on quality initiatives, audits, and validation activities.
What You'll Do
- Conduct internal and external audits, including regulatory inspections and client audits.
- Manage validation activities, including IQ/OQ/PQ, process validation, and computer system validation.
- Collaborate with cross-functional teams to advance quality initiatives and support continuous improvement.
- Review and approve technical documentation, protocols, and reports.
- Support quality professionals.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Knowledge of GMP regulations, ISO 9001 and 13485, and FDA, EMA, and other regulatory requirements; experience with internal and external audits, regulatory inspections, client audits, CAPA, change control, document control, risk management, FMEA, root cause analysis, statistical analysis, validation (IQ/OQ/PQ, process validation, computer system validation), quality management software such as TrackWise and SAP, and data integrity and computer system compliance. Also requires project management and cross-functional leadership abilities, analytical and problem-solving skills, communication skills, ability to review and approve technical documentation, protocols, and reports, and experience supporting quality professionals. Travel up to 25% as required.
Required
- 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
Preferred
- Preferred fields of study: Engineering, Life Sciences, Chemistry, Biology, or related technical/scientific field
- ASQ CQE (Certified Quality Engineer), CQA (Certified Quality Auditor), or relevant industry certifications
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob 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
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.