Bachelor’s 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) Canadian Medical Devices Regulations (SOR/98-282) European Medical Device Directive EU MDD 93/42/EEC
Fluency in English - verbal, written and presentation skills.
Proficiency with all Microsoft Office applications, project management tools, and electronic document control tools.
Strong technical, organizational, and interpersonal skills.
Ability to prioritize, multi-task and perform in a deadline-oriented environment.
Excellent problem solving/decision making skills.
Strong project management and time management skills.
Ability to work closely with multiple internal, external and cross functional teams.
Ability to work in a fast-paced environment and have a strong sense of ownership.
Proactive, collaborative, self-motivated, team player.