Sr. Quality Assurance Specialist
About The Position
The Senior Quality Assurance Specialist is responsible for serving as the primary on-site Quality representative for IDT's Sunnyvale operations while providing quality support for the San Diego facility as needed. This role provides Quality Management System oversight, ensures compliance with applicable regulatory and quality requirements, partners with site leadership to drive continuous improvement, and acts as a liaison between site operations and the broader IDT Quality organization. The position plays a critical role in maintaining compliance, supporting operational excellence, and fostering a culture of quality across multiple California locations. This position reports to the Senior Quality Assurance Manager and is part of the Global Quality Assurance Organization located in Sunnyvale, California and will be an on-site role, with primary support responsibilities for the Sunnyvale site and periodic support for the San Diego facility.
Requirements
- Bachelor's degree in a technical discipline.
- 5+ years of Quality Assurance experience in a regulated life sciences, diagnostics, medical device, or biotechnology environment.
- Demonstrated expertise with ISO 13485 Quality Management Systems.
- Experience supporting audits and regulatory inspections.
- Working knowledge of CAPA, nonconformance, change control, and risk management processes.
Responsibilities
- Serve as the primary on-site Quality representative for Sunnyvale operations and provide quality support for San Diego operations as needed.
- Maintain and support compliance with the IDT Quality Management System and applicable regulatory requirements, including ISO 13485.
- Partner with Operations, Supply Chain, Engineering, Facilities, and R&D teams across both sites to ensure quality requirements are effectively implemented and sustained.
- Support internal and external audits, customer audits, supplier audits, regulatory inspections, and management reviews.
- Monitor site quality metrics and drive continuous improvement initiatives utilizing Danaher Business System tools and methodologies.
Benefits
- paid time off
- medical/dental/vision insurance
- 401(k)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
