Sr. Quality Assurance Specialist

The Senior Quality Assurance Specialist is responsible for serving as the primary on-site Quality representative for IDTs 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.

In this role you will have the opportunity to:

• 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.

The essential requirements of the job include

• Bachelors 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.

Travel Motor Vehicle Record & Physical/Environment Requirements

• Ability to travel up to 25% primarily between Sunnyvale and San Diego with occasional domestic travel.

IDT a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is $103500.00 - $181000.00 USD. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

Join our winning team today. Together well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges architecting solutions that bring the power of science to life.

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