Sr. Quality Assurance Specialist
Danaher Corporation
Summary
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.
Job description
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
- 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.
Travel, Motor Vehicle Record & Physical/Environment Requirements
- Ability to travel up to 25%, primarily between Sunnyvale and San Diego, with occasional domestic travel.
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.
- Ability to travel up to 25%, primarily between Sunnyvale and San Diego, with occasional domestic travel.
Benefits
- Health care program
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Bonus/incentive pay
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.