Quality Engineer

Lead design control and risk management activities for combination product development programs. Support effective risk management activities at external design companies and manufacturing facilities. Ensure combination product development activities are compliant with all required standards. Support the generation of all regulatory submission data. Your Background: Hold a relevant scientific degree or have equivalent working experience. Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, and the EU Medical Devices Regulation. Experience in design controls and risk management for combination products. Familiar with device assembly manufacturing processes. Understand Good Manufacturing Practices (GMP).