The role serves as the operational backbone of the Quality & Compliance function ensuring processes are efficient and inspection-ready
Job Summary
The role serves as the operational backbone of the Quality & Compliance function ensuring processes are efficient and inspection-ready.
Candidates will oversee core quality system processes including document control, CAPA management, and training effectiveness within a regulated clinical technology environment.
The position requires partnering closely with Product, Engineering, and Security teams to embed practical quality controls into business processes.
Matching Summary
The role serves as the operational backbone of the Quality & Compliance function ensuring processes are efficient and inspection-ready.
Skills & Requirements
Must-have
Quality Management System ownership
GxP compliance and data integrity
CAPA lifecycle management
Document control and SOP maintenance
Cross-functional stakeholder partnership
Nice-to-have
Continuous improvement initiatives
Electronic QMS platform experience
Customer audit support skills
SaaS vendor environment background
Strong communication abilities
Key Requirements
12+ years of experience in Quality Systems or Compliance
Bachelor's degree in Life Sciences, Engineering, or related field
Experience in clinical trial software or SaaS healthcare technology
Knowledge of CSV/CSA concepts and validation documentation