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Tier-1 employer, mid-level role, and metro location increase competition, while regulated QA specialization reduces applicant density.
Strong regulatory and CSV/GxP focus makes skills less transferable across industries.
Mandatory 5+ years plus required CSV/GxP/ISO13485 validation expertise creates strict shortlisting filters.
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Provide quality assurance oversight for Digital Health and customer-facing software systems in a regulated environment focusing on review, assessment, and approval of testing and validation activities.
Ensure compliance with 21 CFR Part 11, GAMP, CSV/CSA, ISO 13485, and GxP through risk-based validation and governance across the system lifecycle, integrating QA activities into Agile sprints and releases.
Collaborate with global IT, software development, and business teams and support audit readiness and post-market support activities operating independently on complex QA decisions.
Bachelor’s degree in engineering, computer science, life sciences, or related field.
5+ years of relevant experience in software QA or validation within a regulated environment.
Working knowledge of CSV, CSA, 21 CFR Part 11, change control, impact assessments, GxP systems, and ISO 13485 medical device environment.
Ability to work 1 PM to 10 PM IST across global teams; familiarity with Agile development environments.
Experienced in regulated software validation and quality assurance within digital health or medical device environments with ISO 13485 and GxP compliance focus.
Capable of providing strategic QA guidance independently, particularly in Agile environments supporting global cross-functional teams.
Experienced in supporting audits, regulatory inspections, and working knowledge of tools like Jira or ServiceNow to maintain compliance.