About the Role
Job Summary:
Quality Assurance Engineer responsible for providing design assurance support for new product development and on-market medical devices. The role focuses on facilitating design controls, ensuring regulatory compliance, supporting manufacturing-related design changes, and contributing to verification, validation, and risk management activities throughout the product lifecycle.
Roles & Responsibilities:
Provide design assurance support for new product development and sustaining medical device projects Participate independently in new product development projects to ensure design inputs are clearly defined and met Ensure design verification and validation activities are appropriate, compliant, and support input requirements, including test method validation Conduct thorough reviews and audits of Design History File (DHF) documentation, including design plans, inputs, outputs, v...