Sr Quality Manager

Thermo Fisher Scientific•Marietta, OH

1d•Onsite

About The Position

As a Senior Manager of Quality at Thermo Fisher Scientific, you will guide strategic quality initiatives and support a culture of continuous improvement across our organization. You'll oversee quality management systems, ensure regulatory compliance, and enhance customer experience through excellent quality standards. Working closely with cross-functional teams, you'll develop and implement quality strategies that support our mission of enabling customers to make the world healthier, cleaner, and safer.

Requirements

Minimum Education Required: Bachelor's Degree (Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field)
8 years of operations, manufacturing or continuous improvement experience
5+ years of quality management/leadership experience
Demonstrated experience leading quality investigations, CAPA, and change control processes
Experience implementing continuous improvement initiatives
Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis
Experience hosting regulatory inspections and customer audits
Expert knowledge of global quality standards (ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR)
Excellent ability to be flexible, adaptable, work in fast paced environment, and be proactive
Strong understanding of quality management systems and GMP requirements
Excellent project management and cross-functional leadership abilities
Strong data analysis and problem-solving capabilities
Excellent written and verbal communication skills
Ability to build collaborative relationships at all levels
Proficiency with quality management software systems
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

Professional certifications desired (ASQ, Lean Six Sigma, etc.)
Experience in pharmaceutical, medical device, or regulated life sciences industry preferred

Responsibilities

Manage quality assurance and quality control teams while building strong partnerships with operations, R&D, commercial teams, and customers.
Guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches.
Maintain inspection readiness, managing customer relationships, and ensuring compliance with global regulatory requirements.
Support quality initiatives that deliver consistent product excellence while meeting business objectives.
Develop quality professionals, lead investigations, and implement data-driven solutions that enhance quality systems and customer satisfaction.