Quality Engineer
About The Position
As a Quality Engineer, you will support product quality and manufacturing performance through data analysis, quality processes, and hands-on problem-solving. You will perform data analysis and problem-solving activities to address customer complaints and internal nonconformances. You will also support design of experiments (DOE) and statistical analysis to improve product and process performance. Additionally, you will maintain and support Process and Software Validation Master Plans and Review Board activities, manage and support change orders for products and procedures, and execute product and process improvements through testing, validation, and Agile change management activities. You will maintain and improve the Quality Management System (QMS), including CAPA, SCAR, document control, internal audits, and training, and collaborate with cross-functional teams to ensure compliance with quality standards and continuous improvement.
Requirements
- Bachelor’s degree in Engineering, Sciences, or a related technical field
- Knowledge of Quality Management Systems (QMS) such as ISO 9001, ISO 13485, or FDA 21 CFR 820
- Ability to read and interpret technical drawings and documentation, and develop SOPs
- Familiarity with statistical analysis and problem-solving tools
- Strong analytical, communication, and collaboration skills
Nice To Haves
- Experience in quality, engineering, or manufacturing environments
- Exposure to Six Sigma methodologies
- Experience with Agile PLM or similar systems
Responsibilities
- Perform data analysis and problem-solving activities to address customer complaints and internal nonconformances
- Support design of experiments (DOE) and statistical analysis to improve product and process performance
- Maintain and support Process and Software Validation Master Plans and Review Board activities
- Manage and support change orders for products and procedures
- Execute product and process improvements through testing, validation, and Agile change management activities
- Maintain and improve the Quality Management System (QMS), including CAPA, SCAR, document control, internal audits, and training
- Collaborate with cross-functional teams to ensure compliance with quality standards and continuous improvement
Benefits
- paid time off
- medical/dental/vision insurance
- 401(k)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
