Lead QA Engineer (CSV/Product Software Validation)

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.

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The Lead QA Engineer I is responsible for providing technical and managerial guidance to highly skilled individual contributors and reinforces technical direction of the group. Ensure projects are completed on time within budget and manages the development of processes and procedures to implement functional strategies. Resolves operational problems through collaboration with Software Engineering managers and coordinates resources to meet operational objectives within own area. This position is reported to Software Quality Manager in IDC, Bengaluru

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.

• Defines and oversees validation architecture and software compliance from a system perspective and participate in validation activities to ensure that the software meets the user's needs and workflow requirements in a regulated environment.

• Define and manage validation schedules, coordinate with stakeholders to finalize deliverables and ownership, and influence cross-functional and other functional groups to implement quality improvement

• Act as an advisor to direct reports and may become actively involved when required to meet schedules and handle problems. Administer company policies that have a direct effect on subordinate employees, recommend changes to policies, and management reviews work to measure meeting of objectives.

• Lead and build the team to successfully deliver project releases on time and with desired quality and develop capabilities of the team members.

The essential requirements of the job include:

• BE/BS degree or equivalent work experience in Computer Science or related field with 5+ years in Computer System or Product Software Validation and System Platform Testing, and at least 3+ years leading major projects in regulated environments.

• Ability to work on issues where analysis of situation or data requires review of relevant factors.

• Exercise judgment within defined procedures and policies to determine appropriate action.

• Experience in leading resolution efforts when issues are identified and escalate appropriately and proactively identify and assist in prioritizing opportunities to streamline testing and/or quality but still stay compliant.

• Possess excellent analytical and troubleshooting skills, must be self-motivated, willing to learn new concepts, technologies, and products quickly. Along with strong interpersonal, writing and communication skills, as well as dedication to quality software and customer satisfaction. 

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

• Participated in internal and external audits as a Software subject matter expert.

• Experience with ISO 13485 and risk assessments per ISO 14971, with completing major projects across multiple release cycles. Must have working knowledge of the software development lifecycle in FDA/ISO or other regulated environments

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.