Job Description
Actalent is hiring for a Regulatory Quality Engineer in the Santa Clara area!
Location: Santa Clara, CA (Onsite)
Experience Level: 5–7 years
About the Role
We are seeking a Regulatory Quality Engineer to support the Regulatory Affairs (RA) organization by ensuring compliance with quality systems and regulatory requirements. This role focuses on audit readiness, quality system improvements, risk mitigation, and regulatory compliance activities within a highly regulated environment.
Key Responsibilities
+ Develop and maintain KPI dashboards to monitor regulatory and quality performance metrics
+ Lead and support audit readiness initiatives, including risk identification, mitigation planning, and preventative actions
+ Investigate non-conformances and manage Corrective and Preventive Actions (CAPAs), including implementation and effectiveness monitoring
+ Support and improve quality management system (QMS) processes and procedures
Location: Santa Clara, CA (Onsite)
Experience Level: 5–7 years
About the Role
We are seeking a Regulatory Quality Engineer to support the Regulatory Affairs (RA) organization by ensuring compliance with quality systems and regulatory requirements. This role focuses on audit readiness, quality system improvements, risk mitigation, and regulatory compliance activities within a highly regulated environment.
Key Responsibilities
+ Develop and maintain KPI dashboards to monitor regulatory and quality performance metrics
+ Lead and support audit readiness initiatives, including risk identification, mitigation planning, and preventative actions
+ Investigate non-conformances and manage Corrective and Preventive Actions (CAPAs), including implementation and effectiveness monitoring
+ Support and improve quality management system (QMS) processes and procedures
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