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. 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, 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 Education & Experience: 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

Created: 2026-04-02