Working knowledge of FDA Quality System Regulations, especially Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14970, Risk Management, GMP, and GDP
Ability to effectively work on project teams, including taking leadership role on critical tasks to assure appropriate and timely completion/resolution
Ability to appropriately assess written product and project documentation as an advocate for compliance, and ability to effectively communicate assessment
Strong knowledge of root cause analysis tools and ability to lead root cause activities for complaint investigations, NCs, CAPAs, etc.
Works with high degree of autonomy and independence, requiring minor oversight on complex problems with analysis requiring a variety of factors.
