Quality Engineer 3

📋 Description

• Develops and validates quality assurance procedures, sampling plans, methods, equipment, and
• Monitors manufacturing procedures, processes and records for compliance with established
• Evaluates deviations and non-conformances and supports resolution of quality issues.
• Supports process validation and verification.
• Reviews and trends product and process quality issues using data analysis and root cause
• Responds to quality escalations and provides technical support for troubleshooting and testing.

🎯 Requirements

• Bachelor’s degree in Engineering or Life Sciences
• 1-5 years relevant experience in a medical device company (preferred)
• Demonstrated understanding of medical device QMS requirements and regulatory requirements
• Demonstrated understanding of engineering change controls, process verification and validation, and
• Experience with developing and maintaining Standard Operating Procedures and Work Instructions
• Ability to learn quickly and understand complex products and processes