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..

Senior Software Quality Assurance Specialist