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Entry LevelFull-time
Salary Range
$51,000 - $69,000 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
The Quality Engineer plays a critical role in ensuring manufacturing quality assurance within the plant. This position is responsible for maintaining quality systems, conducting investigations, and ensuring compliance with cGMP and company policies.
Key Responsibilities
- →Implement and maintain the effectiveness of the Quality System
- →Ensure all quality goals are met and practices comply with company policies and regulations
- →Conduct thorough investigations of plant events and document them accurately
- →Perform product impact analyses and place products on QA hold when necessary
- →Maintain effective relationships with other Quality areas and Plant departments
- →Participate on the Validation Review Board as the Manufacturing Quality Assurance function
- →Approve standard operating procedures and ensure they comply with policy
- →Approve calibration requests and ensure appropriate product/process limits are assigned
- →Audit commissioning and validation documentation
- →Develop product quality plans, specifications, and risk analyses
- →Perform batch release for specific U.S. manufacturing sites
Requirements
- ✓Experience in Quality Assurance and Manufacturing environments
- ✓Knowledge of cGMP regulations and quality systems
- ✓Strong understanding of validation, calibration, and CAPA processes
- ✓Ability to conduct thorough investigations and product impact analyses
- ✓Experience with risk analysis and FMEA
- ✓Statistical quality programs and process monitoring systems knowledge
- ✓Excellent communication and interpersonal skills
