Senior Quality Systems Specialist

Make an Impact on Global Health!

Are you ready to unlock your potential and make a meaningful difference in the fields of life sciences, diagnostics, and biotechnology?

At Cepheid, a proud member of the Danaher family of companies, we are committed to saving lives through innovative solutions. Our mission unites us in the pursuit of impactful change, with an emphasis on rapid advancements in healthcare.

Join us and experience a culture where your unique insights are valued. By leveraging Danaher's continuous improvement methodology, you will play a key role in transforming ideas into tangible results - driving innovation at the speed of life.

As a part of our team, you will contribute to the development of advanced molecular diagnostic systems and tests, creating a significant global impact. Together, we strive to tackle the world's most pressing health challenges.

About the Role :

The Senior Quality Systems Specialist will act as the Lead Internal Auditor, responsible for scheduling, planning, executing, and documenting internal audits of Cepheid's Quality Management System (QMS). This role is critical for maintaining rigorous assessments and will facilitate the identification and implementation of effective improvements.

This position reports to the Senior Manager of Quality Systems - Compliance, and is based in our Sunnyvale, CA location. This is an on-site role.

Your Responsibilities Will Include :

• Leading internal audits to assess the QMS, identifying strengths and nonconformances, and driving timely closure through collaboration with nonconformance owners.
• Managing external audit preparations and follow-ups with regulatory bodies including FDA, ISO, and corporate audits.
• Keeping abreast of local, state, and federal regulations to ensure compliance with FDA standards, ISO 13485, IVDR, and other global requirements.

Essential Qualifications :

Additional Details :

Preferred Qualifications :

Cepheid, as part of Danaher, offers a diverse array of competitive benefits that enhance the lives of our employees. From health care coverage to paid time off, our programs are designed to support your well-being.

The annual salary range for this role is $84,100 - $115,800, and this role is also eligible for bonus / incentive pay.

Your compensation package will include comprehensive benefits, such as medical / dental / vision insurance and a 401(k), for eligible employees.

Join us today and help shape the future of science and technology for a better tomorrow, as we partner with clients worldwide to tackle their most complex challenges and deliver impactful solutions.

Cepheid and all Danaher companies value diversity and are committed to equal opportunity employment. We welcome individuals from all backgrounds and provide reasonable accommodations for applicants and employees with disabilities.