Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology
At Cepheid, one of Danaher's 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.
At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring MORE change to the world.
Learn about the Danaher Business System which makes everything possible.
The
QA Validation Associate position that supports quality systems activities related to software validation, with a focus on design control and risk management in accordance with FDA and ISO regulations. This position contributes to the completion of milestones associated with software projects or activities using existing procedures and under direct supervision.
This position is part of the Cepheid Quality Team and will be located at Danaher India Development Center (IDC), Bengaluru, Onsite. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions
In This Role, You Will Have The Opportunity To
- Responsible for the validation of Product Software Systems/ Computer Systems. Perform duties as an individual contributor and/or team member with 100% hands-on work
- Create and update validation deliverables, provide and analyze test data. Support in updating traceability matrices. Ensure that these documents are compliant with internal and external standards. Also, Write, execute, and update test protocols in accordance with SOPs.
- Record, report, and verify software defects to accurately depict the software requirements also work closely with Software Engineering team toward the reporting and resolution of design issues and/or software defects.
- Log, verify, and report software defects to ensure accurate representation of requirements; generate test data for validation report drafts and maintain traceability matrices and quality metrics.
- Manage documentation changes by creating change orders in the document control system and actively participate in daily management activities using DBS tools.
The Essential Requirements Of The Job Include
- BE/BS degree or equivalent work experience in Computer Science, Biology, BioMedical or related field.
- 2+ years of Computer System Validation/ Product Software Validation testing experience in a regulated environment.
- Understanding of FDA and ISO regulations, e.g., design controls, risk management, and software validation.
- Experience with - Windows environments, Web application testing, and working knowledge of SQL, including the ability to run queries, and interpret results.
It would be a plus if you also possess previous experience in:
- Strong interpersonal, written, and verbal communication skills with solid troubleshooting ability; passionate about testing, product quality, and customer satisfaction.
- Self‑motivated professional with a strong willingness to quickly learn new concepts, technologies, and products.
Cepheid, 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 danaherbenefitsinfo.com.
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.
