Senior Software Quality Assurance Specialist

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...