QA Systems Validation Professional

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 will participate in quality system activities related to multiple systems development projects with a focus on executing end to end user workflows 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 is part of the Product Quality department and will be located in Bangalore, India. At Product Quality, our vision is to deliver quality products to our customers.

In This Role, You Will Have The Opportunity To

• Perform duties as an individual contributor and/or team member with 100% hands-on work.
• Prepare and manage key validation documents, including Validation Plans, risk assessments, protocols, test plans, and reports. Ensure that these documents are compliant with internal and external standards.
• Execute validation activities at the system level to ensure the system meets user needs requirements of user workflows for a regulated environment.
• 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.
• Create change orders in document control system. Conduct test design reviews and risk assessments with core team members, influences key stakeholders to drive quality improvements.
  
  

The Essential Requirements Of The Job Include

• BA/BS degree in any Science or Engineering field
• 4+ years of working experience in regulated industry
• Working knowledge in Design controls, IEC-62304, ISO-14971 and ISO-13485 regulations
• Proven history working in a wet lab.
• Experience executing validation activities
  
  

It would be a plus if you also possess previous experience in:

• Quality Engineering certification from American society for quality (ASQ) or other qualifying organizations such as CRE, CQA
• Experience working in molecular diagnostics.
  
  

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.

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.

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