Description

We're looking for a Quality Systems Specialist , working in the Pharmaceuticals and Medical Products industry at 6397 Kaiser Drive, Fremont, California, 94555, United States .

Responsibilities:

• Provide QRM support / expertise to Fremont site via facilitation of risk assessments, authoring of quality risk reports, and delivery of QRM training; support division with revisions to global procedures and sharing of best practices.
• Facilitate / lead risk assessments and author summary reports.
• Use ICH Q9 / ISO 14971 principles and risk management methods / tools to facilitate risk assessments (e.g., FMEA, Fault Tree Analysis, etc.).
• Maintain and make improvements to Quality Risk Management share room and associated QRM resources (e.g., Risk Registry, Periodic Review tracker, etc.).