Sr. Engineer II, QARA (QMS)
Core
Lead and maintain the Quality Management System (QMS) to ensure compliance with regulatory standards and support life sciences diagnostics operations.
Role type
Senior Quality Engineer (QMS)
Builds
Compliant quality systems and audit-ready processes for life sciences instruments
Domain
Life sciences diagnostics and biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS implementation, document control, audit management, CAPA management, eQMS administration, continuous improvement, data analysis, statistical techniques
Preferred skills
ISO 9001/13485 expertise, clinical knowledge, medical device operational experience
Technologies
eQMS, Microsoft Office, Power BI
Responsibilities
Lead QMS implementation and maintenance, manage document control and training, lead internal and external audits, support CAPA and investigations, partner on cross-functional process standardization
Seniority
Senior, hands-on IC
