Quality Systems Specialist

job
  • PSG Global Solutions
Job Summary
Location
Fremont ,CA 94537
Job Type
Contract
Visa
Any Valid Visa
Salary
PayRate
Qualification
BCA
Experience
2Years - 10Years
Posted
15 Mar 2025
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Job Description

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.).
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