QA Engineer III

Thermo Fisher Scientific • St. Louis, MO

1d

About The Position

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 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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)
• Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)
• Expertise in quality systems including:
• 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

Nice To Haves

• Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field
• ASQ certifications (CQE, CQA) desired
• Additional language skills may be beneficial

Responsibilities

• ensure quality excellence and regulatory compliance across manufacturing operations
• ensure our products meet the highest standards while supporting our mission to enable customers to make the world healthier, cleaner and safer
• maintain robust quality management systems
• lead investigations
• drive continuous improvement
• ensure GMP/ISO compliance
• resolve quality issues
• conduct risk assessments
• manage CAPAs
• support audits
• implement quality initiatives
• establish and maintain quality standards
• supporting a culture of continuous improvement and compliance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level