QA Professional I

1 month ago

Bengaluru, India Cepheid Full time

**QA Professional I**

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 which makes everything possible.

Cepheid is looking for a Quality Engineer responsible for performing software verification testing of software products as per medical device standards and regulations. Provides guidance to the core team to organize project structure and documentation to meet design control requirements. Support design changes to established products.

This position is part of Cepheid
- Instrument software 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**:

- Develop and execute Verification plans and protocols and Summary Reports.
- Ensure conformity of the design process with applicable regulation
- Experience of working in an Agile environment, testing requirements
- Review and Approve verification documentation related to the products he/she’s in charge
- Create and compile design control deliverables for regulatory submissions - Traceability Analysis Report and V&V Summary report
- Collaborate with distributed, cross-functional teams to ensure products meet quality, performance, scalability, reliability and scheduled goals
- Works closely with the software development team, the software quality team, the functional manager and the project manager.
- Conduct risk assessment meetings with key stakeholders
- Ensure compliance to organizational policies, procedures, and regulatory requirements such as FDA, ISO 13485

**The essential requirements of the job include**:

- Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences
- 5 years+ experience within the regulated environment of in vitro diagnostics or medical devices
- Fluent in English - written and verbal
- Experience in design verification and/or validation and generation of associated protocols gained either from in house testing simulating end use or actual end use in a clinical environment
- Software development process experience or practical experience with product software verification and/or validation
- Practical experience of workflows in laboratory environments is a plus
- Knowledge of IEC62304, ISO14971, 21CFR820, ISO13485, ISO17025

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

- Experience of software development & testing in a regulated development environment.

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.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful **Danaher Business System** tools and the stability of a tested organization.

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.

If you’ve ever wondered what’s within you, there’s no better time to find out.

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