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 qualified 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 to