QA Validation Associate

5 months ago

Bengaluru Karnataka, India Cepheid Full time

Position - QA Validation Associate

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.

Learn about the Danaher Business System (DBS) 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, 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.
- Participate in the submission, execution, and review of test protocols in accordance with SOPs
- Record, report, and verify software defects to accurately depict the software requirements.
- Participate in test protocol updates and test design reviews
- Work closely with Software Engineering team toward the reporting and resolution of design issues and/or software defects
- Participate in Validation to ensure the software meets user needs requirements of user workflows for a regulated environment.
- Provide test data to drafts of validation report, update traceability matrices and quality metrics.
- Create change orders in document control system.
- Participate in daily management 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.
- Excellent interpersonal, writing and communication skills, and troubleshooting skills and passionate about testing, product quality, and customer satisfaction.
- Self-motivated, willing to learn new concepts, technologies, and products quickly.
- Passionate about testing, product quality, and customer satisfaction.

Hybrid Job Posting Language:
At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part of the time at the Company location identified above and part of the time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.

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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