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 positive 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-organ