Quality Systems Manager
About The Position
As a Quality Systems Manager at Thermo Fisher Scientific, you will contribute to excellence across our quality management systems while enabling our mission to make the world healthier, cleaner and safer. You will guide quality initiatives, support continuous improvement, and cultivate a culture of compliance and operational excellence. Working collaboratively across functions, you will ensure adherence to regulatory requirements while maintaining the highest quality standards for our products and services. This role offers the opportunity to make a meaningful impact by protecting patient safety, supporting innovative research, and enabling critical scientific discoveries.
Requirements
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in quality experience in pharmaceutical, medical device or regulated industry preferred
- Chemistry, Biology, Engineering, Pharmacy, or related scientific/technical field
- 3-5 years of team leadership experience preferred
- Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP)
- Strong understanding of quality tools and methodologies (CAPA, risk analysis, FMEA, root cause analysis)
- Demonstrated ability to develop and mentor quality teams
- Successful experience implementing and improving quality systems
- Skill in cross-functional collaboration and stakeholder management
- Strong analytical and problem-solving capabilities
- Clear written and verbal communication skills
- Proficiency with quality management software (TrackWise, Document Control Systems)
- Experience with continuous improvement methodologies (Lean, Six Sigma)
- Ability to promote quality culture across all levels
- Focus on customer needs and ability to manage customer/supplier relationships
- Project management experience preferred
- Ability to travel up to 25% as needed
- 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
- Relocation assistance is NOT provided.
Responsibilities
- Guide quality initiatives
- Support continuous improvement
- Cultivate a culture of compliance and operational excellence
- Ensure adherence to regulatory requirements
- Maintain the highest quality standards for our products and services
- Protect patient safety
- Support innovative research
- Enable critical scientific discoveries
- Lead internal/external audits and regulatory inspections
- Develop and mentor quality teams
- Implement and improve quality systems
- Collaborate cross-functionally
- Manage stakeholder relationships
- Manage customer/supplier relationships
- Promote quality culture across all levels
- Focus on customer needs
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Manager
