Velsera
Velsera is a company dedicated to powering precision medicine and enhancing the healthcare and life sciences ecosystem through data and actionable insights. It offers advanced genomics interpretation platforms aimed at improving patient care by evaluating clinical significance and generating clinically actionable reports. By integrating workflows, Velsera supports NGS test menus and accelerates 'omics results delivery through automated services. Its technology employs AI and machine learning to automate analysis, providing qualitative results for clinical reporting. Velsera collaborates with research teams, offering tools and expertise in data integration for insights across healthcare and research sectors. With its extensive platform and partnerships, Velsera is a leading provider in the omics analytics market, supporting top pharmaceutical companies and clinical labs globally.
Senior Software Quality Assurance Specialist
October 29, 2024
Velsera
Velsera is a company dedicated to powering precision medicine and enhancing the healthcare and life sciences ecosystem through data and actionable insights. It offers advanced genomics interpretation platforms aimed at improving patient care by evaluating clinical significance and generating clinically actionable reports. By integrating workflows, Velsera supports NGS test menus and accelerates 'omics results delivery through automated services. Its technology employs AI and machine learning to automate analysis, providing qualitative results for clinical reporting. Velsera collaborates with research teams, offering tools and expertise in data integration for insights across healthcare and research sectors. With its extensive platform and partnerships, Velsera is a leading provider in the omics analytics market, supporting top pharmaceutical companies and clinical labs globally.
📋 Description
• 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
• 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 do attitude • Very good oral, written communication, and presentation skills • Good understanding of information security domain (ISO 27001) is a plus
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