Systems Design Quality Engineer-Medical

Job Title

Job Description

Job title: Systems Design Quality Engineer (Medical）
Your Role & Responsibilities:
• Assesses medical device suppliers, products, verification, product safety risk, regulatory compliance for suitability and effectiveness for global markets
• Creates and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, working under limited supervision.
• Handles the entire design control process, from eliciting and validating design inputs to managing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
• Keeps a check on the drafting and updating of detailed quality engineering documents, including quality plans for hardware, software, and system...