Senior Software Quality Assurance Specialist
Summary
QA specialist ensuring compliance and quality for AI-driven healthcare software used in drug discovery and clinical diagnostics.
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...