Job Title : Quality Assurance Consultant Healthcare Domain

Employment Type : Full-Time

Location : Bangalore

Experience : 6-8 Years

Role Purpose :

We are seeking a highly skilled Quality Assurance Consultant with strong experience in IT Quality Management and Healthcare Domain compliance. The ideal candidate will be responsible for ensuring quality governance, regulatory compliance, risk management, and process excellence across healthcare technology projects. This role requires a deep understanding of healthcare ecosystems, quality frameworks, validation processes, and regulatory standards.

Key Responsibilities :

Quality Management & Process Governance :

- Drive quality assurance initiatives across software development and delivery lifecycles.

- Define, monitor, and improve quality metrics, KPIs, and service level agreements.

- Ensure adherence to organizational quality standards and best practices.

- Conduct quality reviews and identify opportunities for continuous improvement.

Compliance & Regulatory Management :

- Ensure compliance with industry standards including ISO 9001 : 2015, ISO 13485, HIPAA, and GDPR.

- Support audit readiness activities and regulatory assessments.

- Maintain documentation controls, traceability matrices, and compliance records.

- Collaborate with stakeholders to ensure adherence to healthcare regulations and quality standards.

Healthcare Domain Quality Assurance :

- Apply knowledge of healthcare ecosystems, including providers, payers, pharmaceutical, and MedTech organizations.

- Understand and evaluate clinical workflows and patient journey processes.

- Support quality initiatives aligned with healthcare business and regulatory requirements.

- Ensure quality processes meet industry-specific compliance and safety standards.

Validation & Documentation Control :

- Manage validation activities and ensure compliance with documentation requirements.

- Maintain audit trails, traceability records, and quality documentation repositories.

- Ensure proper documentation throughout project and product lifecycles.

Risk Management & Compliance Monitoring :

- Identify, assess, and mitigate project and compliance risks.

- Maintain risk logs and track mitigation plans.

- Ensure zero critical-risk leakage through proactive monitoring and governance.

- Facilitate traceable decision-making and compliance adherence across projects.

Quality Metrics & Reporting :

- Define and monitor key quality indicators such as :

1. Defect Density

2. Defect Leakage

3. Test Coverage

4. SLA/KPI Compliance

- Prepare quality reports and present findings to leadership and stakeholders.

- Drive corrective and preventive actions based on quality insights.

Required Qualifications :

Experience :

- 68 years of total experience in IT Quality within IT Services organizations.

- Proven experience in quality governance, compliance, validation, and risk management.

- Experience working on healthcare technology or healthcare-focused projects.

Education :

- Bachelors degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.

Mandatory Skills :

- ISO 9001 : 2015, ISO 13485, HIPAA Compliance, and GDPR Compliance.

- Quality Assurance & Governance.

- Audit Readiness & Documentation Control.

- Risk Management & Mitigation Planning.

- Quality Metrics & KPI Definition.

- Validation & Compliance Processes.

Domain Expertise :

- Strong understanding of Healthcare Ecosystem :

1. Providers

2. Payers

3. Pharmaceutical Organizations

4. MedTech Companies

- Knowledge of Clinical Workflows and Patient Journey.

- Exposure to FDA regulations, compliance processes, and healthcare safety standards.

Preferred Skills :

- Experience in healthcare digital transformation projects.

- Knowledge of quality management frameworks and process improvement methodologies.

- Strong stakeholder management and communication skills.

Behavioral Competencies :

- Strong analytical and problem-solving skills.

- Attention to detail and documentation discipline.

- Proactive risk identification and mitigation mindset.

- Effective communication and stakeholder management.

- Ability to work independently and collaboratively in cross-functional teams.

- High ownership and accountability.

Why Join Us :

- Opportunity to work on healthcare-focused technology initiatives.

- Exposure to global quality and compliance standards.

- Collaborative and growth-oriented work environment.

- Career advancement opportunities in healthcare quality and governance.