Job Description
Job Description
Capability to conduct thorough reviews of new and modified product design documentation, assessing quality characteristics such as manufacturability, serviceability, testability, reliability, and compliance with product requirements.
Subject matter expert in risk management for designated medical device products or platforms.
Ensuring compliance with FDA Quality System Regulations, EU MDR, ISO 13485, ISO 14971, IEC 60601, and other relevant industry standards during product development and changes.
Reviewing Design History Files and Technical Files to ensure alignment with applicable requirements
