Location
Santa Clara, CA, United States
Posted
July 25, 2026
Job Description
Quality Compliance Specialist II– Medical Device
Job Description
The Quality Compliance Specialist supports quality assurance activities in alignment with FDA, European MDD/MDR, and ISO regulations. Working under supervision, this role focuses on nonconformance (NCR) processes, data analysis, internal and external audits, service order records, supplier files, and monitoring key process metrics. The position requires frequent use of established industry practices, techniques, and standards to help maintain and improve the quality management system.
Responsibilities
+ Participate in quality system activities and support internal and external audits in compliance with FDA, European MDD/MDR, and ISO regulations.
+ Coordinate audit-related activities, including preparing documents, tracking audit requests, taking notes, scheduling conference rooms, and setting up communication channels.
+ Interface with subject matter experts to clarify and respond to au...
Job Description
The Quality Compliance Specialist supports quality assurance activities in alignment with FDA, European MDD/MDR, and ISO regulations. Working under supervision, this role focuses on nonconformance (NCR) processes, data analysis, internal and external audits, service order records, supplier files, and monitoring key process metrics. The position requires frequent use of established industry practices, techniques, and standards to help maintain and improve the quality management system.
Responsibilities
+ Participate in quality system activities and support internal and external audits in compliance with FDA, European MDD/MDR, and ISO regulations.
+ Coordinate audit-related activities, including preparing documents, tracking audit requests, taking notes, scheduling conference rooms, and setting up communication channels.
+ Interface with subject matter experts to clarify and respond to au...