Job Description
We are seeking a Senior Design Quality Engineer for a 12-month contract. This role involves ensuring design control compliance, product risk management, and regulatory adherence throughout the product life cycle, particularly for medical devices. Based in Dublin, with 3 days of onsite work required, very competitive hourly rates are available. Key Responsibilities: Support design, development, validation, and risk management for new products. Ensure compliance with FDA, ISO 13485, EU MDR, and other regulations. Oversee design control and risk management tools (e.g., FMEA, FTA). Perform internal and supplier audits. Collaborate with cross-functional teams in engineering, manufacturing, and regulatory functions. Requirements: Bachelor's in science, engineering, or related field (8+ years experience); or MS (4+ years experience). Expertise in medical device design controls, software development, and risk management. Strong problem-solving, leadership, and communication skills. Lead auditor certification and supplier management experience. Skills: Design control medical devices device quality