Velsera

Senior Software Quality Assurance Specialist

Velsera

full-time

Posted on:

Location Type: Hybrid

Location: Pune • India

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Job Level

Senior

About the role

  • 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 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.
  • Recognition & Rewards - Get recognized for your contributions through structured reward programs and campaigns.
  • Engaging & Fun Work Culture - Experience a vibrant workplace with team events, celebrations, and engaging activities that make every workday enjoyable.
  • & Many More...
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
requirements developmenttest planningtest executiontest reportingcompliance assessmentsinternal auditsexternal auditsKPI monitoringquality trainingagile software development
Soft Skills
self-drivenself-organizingindependent workproactiveinitiativeattention to detailoral communicationwritten communicationpresentation skillscollaboration
Certifications
BS Degree in Computer ScienceBS Degree in Information TechnologyBS Degree in Biomedical EngineeringISO 13485ISO 27001