About the Role

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 Systems Validation Professional position supports quality systems activities related to systems 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 systems projects and activities using existing procedures. This position requires a moderate level of guidance and direction and can solve problems and analyze possible solutions using technical experience. This position is part of the Quality department and will be located in the India Development Center, Bengaluru, India.

The Quality department collaborates with cross-functional business partners to ensure that customer needs and safety are met, government regulations and quality requirements are effectively monitored, measured, maintained and continuously improved.

Responsibilities

In this role, you will have the opportunity to:

• Perform 100% hands-on test execution activities as an individual contributor or team member, including writing, executing, and updating test protocols in accordance with SOPs
• Record, report, and verify system and software defects, and support Engineering in defect analysis and resolution to ensure accurate system requirements coverage
• Create and manage change orders in the document control system, and conduct test design reviews and risk assessments aligned with regulated product development processes
• Participate in product validation to confirm system compliance with user needs and regulated workflow requirements, including generation and maintenance of validation deliverables
• Develop and update validation reports, traceability matrices, and quality metrics, and support Product Life Cycle Application Management activities

Qualifications

The essential requirements of the job include:

• BE/BS degree in Biotechnology, Biology, Biomedical Engineering, or related field with 5+ years of system validation or product validation testing experience in regulated environments
• Demonstrated working knowledge of FDA and ISO regulatory requirements, including design controls, risk management, and system validation processes
• Proficiency in Windows environments, web application testing, and SQL, including ability to run queries and interpret results
• Experience executing validation activities and testing workflows in compliance with regulated industry standards
• Ability to lead small validation or testing projects with defined scope, risks, and resource requirements

Benefits

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 Danaher Benefits Info. 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.

About Danaher

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 is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world's most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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