QA / IT Quality Specialist (Healthcare Domain)
$130,000–$170,000 year
On-siteBengaluru, Karnataka, India
Job Summary
Conduct comprehensive quality assurance activities within the healthcare domain, ensuring alignment with ISO 9001:2015 and ISO 13485 compliance standards. Manage audit readiness by maintaining rigorous documentation control and traceability across clinical workflows and patient journeys. Lead risk management and mitigation planning while adhering to FDA regulatory processes and global data privacy frameworks like HIPAA and GDPR. Monitor QA metrics including defect density, leakage, and test coverage to drive continuous improvement. This role supports providers, payers, pharma, and MedTech ecosystems, requiring 6–8 years of experience in IT services quality assurance.
Required Qualifications
- ISO 9001:2015, ISO 13485 compliance
- HIPAA & GDPR knowledge
- Strong understanding of Healthcare ecosystem (Providers, Payers, Pharma, MedTech)
- Knowledge of clinical workflows & patient journey
- Exposure to FDA regulatory & compliance processes
- QA metrics (Defect density, leakage, test coverage, KPI/KLA)
- Audit readiness, documentation control & traceability
- Risk management, mitigation planning & compliance adherence
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