Sr. Manager, Quality
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Job Location:
Middletown, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
Discover Impactful Work:
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. Youll oversee quality management systems ensure regulatory compliance and enhance customer experience through excellent quality standards. Working closely with cross-functional teams youll develop and implement quality strategies that support our mission.
In this role youll manage quality assurance and quality control teams while building strong partnerships with operations R&D commercial teams and customers. Youll guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches. Your leadership will be essential in maintaining inspection readiness managing customer relationships and ensuring compliance with global regulatory requirements.
As a member of the site leadership team youll support quality initiatives that deliver consistent product excellence while meeting business objectives. Youll develop quality professionals lead investigations and implement data-driven solutions that enhance our quality systems and customer satisfaction.
This is a fully onsite position based in Middletown VA.
Relocation assistance is NOT provided.
Keys to Success:
Education
- Advanced degree with 6 years of experience OR
- Bachelors degree with 8 years of experience.
- Preferred: Science Engineering Chemistry or related technical field.
Experience
- 5 years of quality management/leadership experience.
- Professional certifications desired (ASQ Lean Six Sigma etc.).
- 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.
Knowledge Skills Abilities
- Expert knowledge of global quality standards (ISO 13485 ISO 9001 FDA 21 CFR 820 EU MDR/IVDR).
- 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.
- Experience hosting regulatory inspections and customer audits.
- Proficiency with quality management software systems.
- Ability to travel up to 25%.
- Must be legally authorized to work in the United Stateswithoutsponsorship.
- Must be able to pass a comprehensive background check whichincludes a drug screening.
Required Experience:
Manager
Key Skills
- APQP
- Quality Assurance
- ISO 9001
- Lean Six Sigma
- PPAP
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Control
- Quality Management
- As9100
- Manufacturing
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
