Principle Quality Engineer
Modis
(St. Louis, Missouri)At Modis, we use our insight, knowledge and global resources to make exceptional connections every day. With 70 branch offices located strategically throughout North America, we are positioned perfectly to deliver the industry's top talent to each of our clients. Clients choose Modis as their workforce partner to s
This position involves resolving the equipment and process-related production issues, activities including equipment, process, materials and method validation. There will also be a strong focus on performing root cause analysis of quality issues.
- Support the qualification and validation of new/changed processes and products, including performance.
- Perform testing, data generation and data analysis as necessary, through the knowledge and use of statistical problem solving techniques.
- Track, investigate and report on major quality issues and indicators necessary for the successful operation of the St. Louis quality system.
- Plan, prioritize, set goals and manage multiple projects in a technical and business environment.
- Bachelor's degree in technical field
- Minimum three years experience in validation
- Quality engineering certification preferred (CQE, SSGB, SSBB)
- Knowledge of quality, regulatory affairs, FDA regulations
- Experience with failure analysis and root cause
Questions
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- Data Analysis
- Technical Skill
- Quality System
- Knowledge of U.S FDA Regulations and Standards
- Regulatory Affairs
- Business
- Quality Engineering
- ASQ Certified Quality Engineer (CQE)
- Six Sigma Green Belt
- Six Sigma Black Belt
- Failure Analysis
- Data generating

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