Quality Engineer III

Thermo Fisher Scientific • Marietta, OH

1d • Onsite

About The Position

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.

Requirements

• Bachelor's Degree (Preferred Fields of Study: Mechanical or Industrial Engineering or related technical field)
• 2+ years of experience in quality assurance in regulated industry (pharmaceutical, medical device, or biotech)
• Expertise in quality systems including: CAPA and deviation management, change control, risk management, FMEA, document control and internal/ external auditing
• Experience with validation and qualification protocols
• Working knowledge of ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)
• 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
• 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
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

Nice To Haves

• ASQ certifications (CQE, CQA) desired
• Additional language skills may be beneficial

Responsibilities

• Be the SME within the quality group by being hands on in resolving quality issues, conducting risk assessments and managing CAPAs
• Support audits
• Implement quality initiatives
• Interface and influence stakeholders on quality issues/ updates
• Interface effectively with internal teams and external customers/regulators
• Establish and maintain quality standards
• Support a culture of continuous improvement and compliance

Benefits

• Competitive compensation
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Innovative, forward-thinking organization
• Outstanding career and development prospects
• Exciting company culture that stands for integrity, intensity, involvement, and innovation!

What This Job Offers

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