Quality Engineer

22 hours ago

Remote, India Open Hand Solutions Full time ₹ 8,00,000 - ₹ 24,00,000 per year
Job Description
  • 5+ years experience in a software engineering organization in a development or quality engineering role
  • Understanding of FDA, ISO, HIPAA, SOC2, and other regulations and standards
  • Sound knowledge of IEC 62304: Medical device Software – Software life cycle processes. 
  • Working knowledge of different SDLCs (software development life cycle), particularly agile scrum
  • Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
  • Demonstrated ability to advocate for product excellence and quality.
  • Knowledge of cloud-based technologies such as Amazon Web Services
  • Experience working in a regulated environment preferably in software medical device R&D
  • Must possess strong project management skills as well as the ability to manage multiple tasks simultaneously
  • Demonstrated ability to test, review defects and inspect software and/or code
  • Work with leadership and team members to solicit process requirements and drive organizational change for continuous process improvements.
  • Perform risk analysis and develop mitigation strategies as appropriate.
  • Lead, mentor, and work with the local and remote testing teams across the globe to drive verification and validation efforts

Skills:
  • Understanding of Quality Management Systems for Medical Devices
  • Familiarity or experience with Corrective Action and Preventive Action (CAPA) process
  • Strong experience in Documentation and Reviews
  • Excellent interpersonal communication skills

Location: Chandigarh & WFH Please email cv on , with notice period , current gross per month and expected gross per month , immediate joiners preferred

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