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
Bachelor’s 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 :  
with subject “QA Specialist Compliance & Data Security ”

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.