Senior Software Quality Assurance Specialist

October 29

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Velsera

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501 - 1000

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