Quality Assurance Specialist

Job Title: QA Specialist – IT Compliance & Data Security Organization: Nipro India HealthcareLocation: New Delhi / Hyderabad IndiaReporting To: Manager – Manager RA / QA & IT ManagerPosition SummaryNipro India Health Care R&D Skill Development Center is seeking a detail-oriented and experienced QA Specialist – Compliance & Data Security responsible for ensuring adherence to ISO standards, patient data protection requirements, IT governance norms, and all relevant Indian healthcare and information security regulations.The role will focus on quality assurance controls across cloud infrastructure, on-premise servers, patient data systems, and clinical information management processes, ensuring full regulatory and certification compliance.Key Responsibilities1. ISO & Quality Management ComplianceSupport implementation and maintenance of: ISO 27001 – Information Security Management System (ISMS), ISO 9001 – Quality Management System. ISO 13485 – (where applicable to R&D activities)Overall Security ManagementData Privacy (GDPR/HIPAA)ISO 27701, ISO 27018, ISO 27799Wearable Device QualityISO 13485Risk Management (Wearables)ISO 14971Software DevelopmentIEC 62304, IEC 62366Remote Monitoring/TelehealthISO 13131, ISO/IEEE 11073Conduct internal audits and assist during external certification audits.Develop, review, and maintain SOPs related to IT systems, data handling, and QA controls.Track CAPA (Corrective and Preventive Actions) and ensure timely closure.2. Regulatory Compliance : Indian IT & Healthcare Laws . Ensure compliance with applicable Indian laws including:Information Technology Act, 2000 and SPDI RulesDigital Personal Data Protection Act, 2023Clinical Establishments (Registration and Regulation) Act, 2010 (if applicable)Drugs and Cosmetics Act, 1940 (where relevant to R&D/clinical activities)Monitor regulatory updates and recommend policy changes.Ensure patient rights and privacy requirements are embedded in all processes.3. Cloud & On-Premise Infrastructure ComplianceValidate security controls for:Cloud servers (IaaS/PaaS/SaaS environments)On-premise data centers and local serverEnsure:Data encryption (at rest & in transit)Secure access control (RBAC, MFA)Backup & disaster recovery complianceLog monitoring and audit trailReview vendor compliance documentation and SLAs.Conduct risk assessments and vulnerability assessments in coordination with IT teams.4. Patient Data Safety & Information PrivacyEnsure lawful processing of patient data and clinical training records.Verify consent management, data minimization, and retention policies.Support implementation of data protection impact assessments (DPIA).Monitor incident response procedures for data breaches.Ensure compliance with patient rights including:Right to informationRight to access dataRight to correctionRight to grievance redressal5. Audit & ReportingConduct scheduled and surprise internal audits.Maintain compliance registers and risk logs.Prepare audit reports and management summaries.Assist in third-party and regulatory inspections.Required QualificationsBachelor’s degree in: Information Technology / Computer Science / Biomedical Engineering / Healthcare Management / Quality ManagementCertification preferred:ISO 27001 Internal AuditorISO 9001 Internal AuditorCertified Information Security / Data Privacy certificationsExperience5-10 years of experience in: Healthcare QA or IT compliance, Information security audits, ISO implementation and maintenanceClinical or medical device documentation qualityExperience working with:Cloud platforms (AWS / Azure / GCP)Server security managementHealthcare data privacy frameworksKey CompetenciesStrong understanding of Indian IT & healthcare regulationsKnowledge of data security principles & cybersecurity controlsRisk assessment and audit capabilityDocumentation and SOP managementAttention to detail and analytical thinkingStrong communication and stakeholder coordination skillsKey Performance Indicators (KPIs)Zero major audit non-conformitiesTimely closure of CAPAs100% compliance documentation coverageNo critical data privacy violationsSuccessful ISO audit outcomesInterested candidate apply by Email to : with subject “QA Specialist Compliance & Data Security ”Corporation, headquartered in Osaka, Japan, is a global leader in the healthcare industry, serving healthcare professionals, pharmaceutical companies, and patients. For over seven decades, Nipro has been dedicated to developing, manufacturing, and delivering high-quality medical devices, medicines, and pharmaceutical packaging that improve patient outcomes. With over 38,000 employees worldwide, Nipro strives to innovate and create value-added products and technologies that contribute to better healthcare globally. The company is deeply committed to enhancing lives and ensuring a healthier future for all.

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