Medical Device Software Quality Engineer (East Coast USA)

The Medical Device Software Quality Engineer will support software quality for medical device product development, day-to-day Quality Management System (QMS) operations to ISO 13485:2016 and MDSAP requirements, and assist with regulatory compliance activities for medical software primarily in the US and Canadian markets.

Requirements

• Degree or equivalent in a relevant discipline (e.g. life sciences, engineering, quality management, regulatory affairs) or equivalent experience.
• Training or coursework in ISO 13485 or quality management systems is desirable.
• Regulatory affairs training (e.g. RAC coursework) or internal audit training is an advantage.
• Minimum 3 years of experience in a quality, regulatory, or related role in a medical device, IVD, pharmaceutical, or regulated software environment