QA Validation Professional

2 months ago

Bangalore, India Danaher Full time

The Software Quality Validation Engineer 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 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 Cepheid Quality Team and will be located at Danaher India Development Center (IDC), Bengaluru, Hybrid. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions. 

 

In this role, you will have the opportunity to: 

  • Perform duties as an individual contributor and/or team member with 100% hands-on work 

  • 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. 

  • 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. 

  • Participate in product validation to ensure the software meets user needs requirements of user workflows for a regulated environment. 

  • Create and update validation deliverables, provide and analyse test data to drafts of validation report. Generate and update traceability matrices and quality metrics. 

  • Experience with Product Life Cycle Application Management 

  • Builds knowledge of the company processes and customers 

 

The essential requirements of the job include 

  • BE/BS degree or equivalent work experience in Computer Science, Biology, BioMedical or related field. 

  • 3+ 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.  

  • Self-motivated, willing to learn new concepts, technologies, and products quickly. 

  • Excellent interpersonal, writing and communication skills, and troubleshooting skills. 

  • Passionate about testing, product quality, and customer satisfaction. 

  • Able to train and help colleagues with less experience; be able to lead small projects with manageable risks and resource requirements 

 

Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether itâs a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at danaherbenefitsinfo.com. 

At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrowâs 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. Our global teams are pioneering whatâs next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

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