Filtration Sr. Quality Engineer Columbia, MO
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Job Location:
Columbia, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
17 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Position: Filtration Sr. Quality Engineer
Location: Columbia MO
Schedule: Typical M-F Days some occasional weekend work
Division / Site Specific Information
This role supports manufacturing operations within Thermo Fisher Scientific partnering cross-functionally with Operations Engineering Regulatory and Supply Chain teams to ensure quality excellence and regulatory compliance across the site.
Discover Impactful Work
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 dayenabling our customers to make the world healthier cleaner and safer.
As a Quality Engineer III you will play a critical role in ensuring our products meet the highest quality and regulatory standards. Youll combine technical expertise with quality leadership to support robust quality systems drive continuous improvement and ensure compliance with GMP and ISO requirements while supporting solutions for some of the worlds toughest challenges.
A Day in the Life
- Ensure compliance with current Good Manufacturing Practices (cGMPs) ISO 13485/9001 standards and applicable global regulatory requirements (FDA EMA etc.)
- Lead and support quality system activities including CAPA deviation management change control and document control
- Conduct root cause analysis risk assessments and FMEA to identify and mitigate quality risks
- Support internal and external audits inspections and customer interactions
- Partner cross-functionally to resolve quality issues and drive continuous improvement initiatives
- Support validation and qualification activities as required
- Analyze quality data using statistical tools to identify trends and improvement opportunities
- Maintain accurate quality documentation and ensure timely completion of quality records
Keys to Success
Education
- Advanced Degree with a minimum of 3 years of experience OR
- Bachelors Degree with a minimum of 5 years of experience
- Preferred fields of study: Engineering Life Sciences Chemistry or related technical discipline
Experience
- Experience in quality assurance within a regulated industry (pharmaceutical medical device or biotechnology)
- Hands-on experience with quality systems including CAPA deviations change control risk management and document control
- Experience supporting or leading internal and external audits
- Experience with validation and qualification protocols
- Experience working cross-functionally in a manufacturing environment
Knowledge
- Strong understanding of cGMPs ISO 13485/9001 and global regulatory requirements
- Knowledge of statistical analysis methods and quality tools
Skills
- Advanced problem-solving and root cause analysis skills
- Strong project management capabilities
- Proficiency with quality management systems and Microsoft Office
- Excellent verbal and written communication skills
Abilities
- Ability to work independently and collaboratively in a fast-paced environment
- Strong attention to detail while maintaining a broad quality perspective
- Ability to effectively interface with internal teams customers and regulatory agencies
- Up to 25% travel may be required
- Additional language skills are a plus
Other
- Must be legally authorized to work in the United States without sponsorship now or in the future
- Must be able to pass a comprehensive background check including a drug screening
Required Experience:
Senior IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- 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
