Quality Assurance Engineer

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.

• 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, verification, validation, design changes, and design transfer documentation
• Review and audit Requirements Trace Matrix to ensure accuracy and compliance with medical device design control requirements
• Support sustaining product projects by ensuring continued compliance with design inputs and completion of required verification, validation, and risk management activities
• Collaborate with R&D to coordinate design elements of Risk Management files in compliance with applicable standards and internal policies
• Coordinate Health Risk Assessment activities for on-market products, including problem definition, impact analysis, and evaluation
• Assess product change requests for design impact and determine required supporting information for implementation
• Act as a key advocate for compliance by reviewing product and project documentation and communicating assessments effectively
• Work collaboratively on cross-functional project teams and take leadership on critical tasks as needed

• Bachelor's degree in a technical discipline
• 2 5 years of experience, preferably in the medical device industry
• Experience with FDA Quality System Regulations, especially Design Control requirements
• Knowledge of ISO 13485, Medical Device Directive, and ISO 14971 Risk Management
• Familiarity with usability, reliability, electrical safety, software, sterilization, packaging, and biocompatibility standards
• Working knowledge of verification and validation requirements for regulated products
• Experience in requirements analysis and development of testable and measurable specifications
• Strong ability to work effectively within project teams with good communication and compliance-focused judgment