Quality Assurance Specialist

Job Title: QA Specialist IT Compliance & Data Security

Organization: Nipro India Healthcare

Location: New Delhi / Hyderabad India

Reporting To: Manager Manager RA / QA & IT Manager

Position Summary

Nipro 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 Responsibilities

1. ISO & Quality Management Compliance

• Support 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 Management
• Data Privacy (GDPR/HIPAA)
• ISO 27701, ISO 27018, ISO 27799
• Wearable Device Quality
• ISO 13485
• Risk Management (Wearables)
• ISO 14971
• Software Development
• IEC 62304, IEC 62366
• Remote Monitoring/Telehealth
• ISO 13131, ISO/IEEE 11073
• Conduct 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 Rules
• Digital Personal Data Protection Act, 2023
• Clinical 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 Compliance

• Validate security controls for:
• Cloud servers (IaaS/PaaS/SaaS environments)
• On-premise data centers and local server
• Ensure:
• Data encryption (at rest & in transit)
• Secure access control (RBAC, MFA)
• Backup & disaster recovery compliance
• Log monitoring and audit trail
• Review vendor compliance documentation and SLAs.
• Conduct risk assessments and vulnerability assessments in coordination with IT teams.

4. Patient Data Safety & Information Privacy

• Ensure 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 information
• Right to access data
• Right to correction
• Right to grievance redressal

5. Audit & Reporting

• Conduct 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 Qualifications

• Bachelors degree in: Information Technology / Computer Science / Biomedical Engineering / Healthcare Management / Quality Management

Certification preferred:

• ISO 27001 Internal Auditor
• ISO 9001 Internal Auditor
• Certified Information Security / Data Privacy certifications

Experience

5-10 years of experience in: Healthcare QA or IT compliance, Information security audits,

• ISO implementation and maintenance

Clinical or medical device documentation quality

Experience working with:

• Cloud platforms (AWS / Azure / GCP)
• Server security management
• Healthcare data privacy frameworks

Key Competencies

• Strong understanding of Indian IT & healthcare regulations
• Knowledge of data security principles & cybersecurity controls
• Risk assessment and audit capability
• Documentation and SOP management
• Attention to detail and analytical thinking
• Strong communication and stakeholder coordination skills

Key Performance Indicators (KPIs)

• Zero major audit non-conformities
• Timely closure of CAPAs
• 100% compliance documentation coverage
• No critical data privacy violations
• Successful ISO audit outcomes

Interested candidate apply by Email to : jobs@nipromedindia.com

with subject QA Specialist Compliance & Data Security

www.nipro.co.jp

www.niproinindia.com

Nipro 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.