Design Quality Assurance Engineer

Job Summary

To support product development and lifecycle processes, the full-time Design Quality Assurance Engineer will manage design controls, risk assessments, and validation activities while collaborating with cross-functional teams in a remote environment.

Key responsibilities

• Review and approve protocols, reports, and compliance documents related to Research and Development activities
• Lead efforts to resolve product quality issues and analyze post-market data for improvement recommendations
• Oversee Computer System Validation activities and ensure compliance with FDA regulations and ISO standards

Required qualifications

• Bachelor's degree in engineering or a related field with 2-4 years of experience in the medical device or regulated industry
• Expert understanding of global medical device regulations, including ISO 13485 and 21 CFR 820
• Knowledge of Risk Management (ISO 14971), Biocompatibility (ISO 10993), and Sterilization standards (ISO 11135 & ISO 11137)
• Familiarity with IEC 60601 and automated testing tools
• Demonstrated competency in project management and effective communication skills