Sr. Quality Assurance Specialist
Core
Primary on-site Quality representative for Sunnyvale operations supporting San Diego, ensuring compliance with regulatory requirements and the Quality Management System.
Role type
Senior Quality Assurance Specialist (Life Sciences)
Builds
Compliance with ISO 13485 and regulatory standards for diagnostics and biotechnology products.
Domain
Life sciences, diagnostics, biotechnology
Deliverable
dashboards & analysis
Required skills
ISO 13485 expertise, audit support, CAPA, nonconformance management, change control, risk management, continuous improvement methodologies
Preferred skills
None stated
Technologies
None stated
Responsibilities
Serve as primary on-site Quality representative for Sunnyvale operations; Maintain and support compliance with the IDT Quality Management System and applicable regulatory requirements; Partner with Operations, Supply Chain, Engineering, Facilities, and R&D teams; Support internal and external audits, customer audits, supplier audits, regulatory inspections, and management reviews; Monitor site quality metrics and drive continuous improvement initiatives.
Seniority
Senior, hands-on IC