Sr. Quality Assurance Specialist

Danaher Corporation; Sunnyvale (CA); On-site; USD 104,000 - 181,000; Full time

Benefits offered by this job

Bonus eligible

Benefits package including health, 401

Paid time off

Job summary

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Senior Quality Assurance Specialist to lead on-site quality for Sunnyvale with support for San Diego. You will maintain the Quality Management System, drive regulatory compliance, and collaborate with multi-functional teams to ensure robust QA processes.

The role emphasizes audits, CAPA, and risk management, with travel up to 25% between Sunnyvale and San Diego.

Qualifications

• 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.

Skills

Quality Assurance

Audits

Regulatory compliance

CAPA

Change control

Risk management

Education

Bachelor’s degree in a technical discipline

Tools

ISO 13485 knowledge

CAPA tooling

Change control

Risk management processes

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Integrated DNA Technologies (IDT), one of Danaher’s (https://danaher.com/our-businesses) 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Our team at Integrated DNA Technologies (IDT), is united by a commitment to collaboration and scientific excellence, building on a strong foundation of innovation, expertise, and reliability. Guided by our vision to help researchers rapidly move from the lab to life-changing advances, we work closely with global partners to accelerate progress and genomics breakthroughs across fields like cancer, infectious disease, rare genetic disorders, and more. At IDT, you’ll be part of a culture rooted in continuous learning and improvement—where your growth fuels our mission to accelerate the pace of genomics and helps shape a healthier, brighter future for all.

Learn about the Danaher Business Syste m which makes everything possible.

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.

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.

IDT, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .

The annual salary range for this role is $ 103,500.00 – $181,000.00 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.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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.

For more information, visit www.danaher.com.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click here (https://jobs.danaher.com/global/en/notice-to-us-candidates-based-in/applying-for-roles-outside-nyc) .

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].