Quality Specialist III - Engineering Support

Thermo Fisher Scientific • Cincinnati, OH

1d • Onsite

About The Position

As part of Thermo Fisher Scientific, the Quality Specialist III supports the company’s mission to enable customers to make the world healthier, cleaner, and safer. The role maintains regulatory compliance and drives continuous improvement of quality systems. It collaborates with cross-functional teams to investigate quality issues, conduct audits, manage documentation, and implement corrective actions while fostering a culture of quality excellence.

The position is based in an office environment, with some degree of personal protective equipment required. It may involve working in manufacturing environments with PPE as needed and travel of up to 25%. The schedule is first shift (days). Relocation assistance is not available. Applicants must be legally authorized to work in the United States without current or future employer-sponsored work authorization. Employment is contingent on applicable pre-employment screening, including a background check and drug screening.

Requirements

• Advanced degree plus 3 years of experience, or a bachelor's degree plus 5 years of experience, in quality assurance or quality control within regulated industries.
• Strong knowledge of GMP/GxP regulations, ISO standards (9001/13485), and other relevant quality system requirements.
• Experience with quality management systems, CAPA processes, deviation management, and change control.
• Expertise in root cause analysis, investigation techniques, and corrective action implementation.
• Proficiency in statistical analysis, data trending, and quality metrics reporting.
• Strong technical writing skills for authoring SOPs, investigation reports, and other quality documentation.
• Experience conducting and hosting internal and external audits and regulatory inspections.
• Advanced problem-solving abilities and attention to detail.
• Excellent verbal and written communication skills.
• Strong interpersonal skills and ability to collaborate across functions and levels.
• Proficiency with quality systems software, such as TrackWise and document control systems, and Microsoft Office Suite.
• Ability to work independently and guide cross-functional teams.
• May require up to 25% travel.
• Physical ability to work in manufacturing environments with PPE requirements as needed.
• Applicants must be legally authorized to work in the United States without current or future employer-sponsored work authorization.

Nice To Haves

• Preferred fields of study include Life Sciences, Engineering, Chemistry, Biology, or a related technical field.
• Experience in pharmaceutical, medical device, or biotech industries is preferred.
• Knowledge of risk assessment methodologies and continuous improvement tools.
• Project management experience preferred.

Responsibilities

• Maintain regulatory compliance and drive continuous improvement of quality systems.
• Collaborate with cross-functional teams to investigate quality issues.
• Conduct and host internal and external audits and regulatory inspections.
• Manage quality documentation, including authoring SOPs and investigation reports.
• Implement corrective actions and support CAPA, deviation management, and change control processes.
• Conduct root cause analysis and investigations.
• Perform statistical analysis, data trending, and quality metrics reporting.
• Guide cross-functional teams and support quality excellence across the organization.

What This Job Offers

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