Senior Software Quality Assurance Specialist

We are seeking a Senior Software Quality Assurance Specialist to support implementation of Integrated Management Systems SOPs, compliance assessments, and quality related trainings. The ideal candidate will have a BS degree in Computer Science, Information Technology or Biomedical Engineering, and 5+ years of relevant industry experience.

Requirements

• BS Degree in Computer Science, Information Technology or Biomedical Engineering or equivalent degree
• 5+ years of relevant industry experience
• Sound knowledge of Industry standards: (e.g., ISO 13485,)
• 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
• Health & Well-being
• Growth & Learning
• Engaging & Fun Work Culture