Senior Software Quality Assurance Specialist

Velsera; Pune District; Hybrid; INR 1,200,000 - 2,100,000; Full time

Benefits offered by this job

Hybrid work model

Unlimited paid time off

Group medical and life insurance

Employee Assistance Program (EAP)

Learning & development

Job summary

Velsera is seeking a Quality & Regulatory Compliance professional to support implementation of Integrated Management Systems SOPs and manage compliance across product lifecycle. You will work on audits, CAPAs, and regulatory activities in a hybrid work model.

The ideal candidate has 5+ years of relevant industry experience, strong ISO 13485 knowledge, experience with 21 CFR Part 820 & 11, EU MDR/IVDR, and excellent English communication. This role offers growth and cross-functional collaboration.

Qualifications

• BS degree in CS/IT/biomedical engineering or equivalent.
• 5+ years in quality/regulatory with proven achievements.
• Strong knowledge of ISO 13485 and regulatory requirements (21 CFR Part 820/11, EU MDR/IVDR, Annex 11).
• Experience applying agile in regulated environments.
• Fluent in English.

Responsibilities

• Support implementation of Integrated Management Systems SOPs.
• Support all phases of the product life cycle (requirements, test planning/execution, reporting).
• Assist in compliance assessments to ensure regulatory requirements are met.
• Participate in continuous improvement initiatives.
• Assist in internal and external audits and CAPA closures.
• Track KPIs and provide quality trainings.
• Collaborate across teams to deliver responsibilities.

Skills

Regulatory compliance

ISO 13485

Quality Assurance

Audits & CAPA

Agile in regulated env

English fluency

Self-driven & initiative

Education

BS Degree in Computer Science, Information Technology or Biomedical Engineering or equivalent degree

Job 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

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

• 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 Assurance 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...