# Senior Software Quality Assurance Specialist

> Velsera · Pune, India (Hybrid) · Full-time · Posted 2026-05-04

**Workplace:** hybrid

**Department:** PR.4 Quality & Regulatory Affairs

## Description

**About Velsera**

Medicine moves too slow. At Velsera, we are changing that.

Velsera was formed in 2023 through the shared vision of Seven Bridges and Pierian, with a mission to accelerate the discovery, development, and delivery of life-changing insights.

Velsera provides software and professional services for:

-   AI-powered multimodal data harmonization and analytics for drug discovery and development
-   IVD development, validation, and regulatory approval
-   Clinical NGS interpretation, reporting, and adoption

With our headquarters in Boston, MA, we are growing and expanding our teams located in different countries!

**What will you do?**

-   Support implementation of Integrated Management Systems SOPs
-   Support all phases of the product life cycle (including, but not limited to requirements development/review/approval, test planning, test execution, and test reporting and assessment)
-   Support compliance assessments to ensure quality and regulatory requirements are successfully implemented and maintained
-   Participate in assigned continuous improvement initiatives
-   Conduct activities related to internal and external audits as assigned
-   Track Non-Conformities and CAPAs to closure cross organization
-   Timely monitor and report on KPIs
-   Provide quality related trainings
-   Collaborate across teams to deliver the responsibilities

## Requirements

**What do you bring to the table?**

-   BS Degree in Computer Science, Information Technology or Biomedical Engineering or equivalent degree
-   5+ years of relevant industry experience with demonstrated achievements in the areas of responsibilities mentioned above.
-   Sound knowledge of Industry standards: (e.g., ISO 13485,) and good understanding of Regulatory requirements: 21 CFR Part 820 & Part 11, EU MDR or IVDR, Annex 11
-   Good understanding of agile software development support ways of implementing agile principles in a regulated environment.
-   Fluency in English
-   Knowledge & experience of managing compliance using software tools
-   Quick learner, self-driven & self-organizing and able to work independently
-   Proactive and with ability to take initiative
-   Precise, accurate, with an eye on details and can to attitude
-   Very good oral, written communication, and presentation skills
-   Good understanding of information security domain (ISO 27001) is a plus

## Benefits

-   Flexible Work & Time Off - Embrace hybrid work models and enjoy the freedom of unlimited paid time off to support work-life balance.
-   Health & Well-being - Access comprehensive group medical and life insurance coverage, along with a 24/7 Employee Assistance Program (EAP) for mental health and wellness support.
-   Growth & Learning - Fuel your professional journey with continuous learning and development programs designed to help you upskill and grow.
-   Engaging & Fun Work Culture - Experience a vibrant workplace with team events, celebrations, and engaging activities that make every workday enjoyable.
-   & Many More...

## Apply

[Apply at Velsera](https://apply.workable.com/velsera/j/DCA9CAE879/apply)

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