Bachelors degree in related discipline
Minimum 4 years in a medical device, life sciences or similar industry.
Experience in a software development industry preferable.
Experience in performing internal/external/supplier audits preferable.
Working knowledge of medical device regulations and standards applicable to IWCS products, including:
ISO 13485 Medical Device Quality System Requirements,
ISO 14971 Medical Device Risk Management
FDA Quality System Regulation (21 CFR 820)
Years of Experience: