Sr. Quality Assurance Specialist
Core
Primary on-site Quality representative for IDT's Sunnyvale operations, ensuring compliance with regulatory requirements and the Quality Management System while supporting San Diego facility as needed.
Role type
Senior Quality Assurance Specialist (Life Sciences/Medical Device)
Builds
Compliance with ISO 13485 and regulatory standards for life sciences diagnostics and biotechnology products.
Domain
Life Sciences, Diagnostics, Biotechnology, Medical Devices
Required skills
ISO 13485 QMS expertise, audit support (internal/external/customer/regulatory), CAPA, nonconformance, change control, risk management, continuous improvement methodologies
Preferred skills
None stated
Technologies
Danaher Business System tools
Responsibilities
Serve as primary on-site Quality representative for Sunnyvale operations, maintain compliance with IDT Quality Management System and regulatory requirements, partner with Operations/Supply Chain/Engineering/Facilities/R&D teams, support audits and regulatory inspections, monitor quality metrics and drive continuous improvement initiatives
Seniority
Senior, hands-on IC
