Qa Lead

QA Lead

Experience: 8+ Years  | Location: Trivandrum / Hybrid  | Employment Type: Full-time

Role Overview

We are looking for an experienced QA Lead with 8+ years of experience in software quality assurance and product development. The ideal candidate should have strong experience in SaaS product development, QA processes, compliance, audits, and quality management. The candidate should be capable of independently driving QA processes, supporting audits, identifying process gaps, and guiding the QA team to ensure high-quality, traceable, and compliant product releases.

Key Responsibilities

• Lead QA activities across the complete SaaS product lifecycle, from requirements and risk assessment through test execution, release validation, and production release.
• Define and implement QA strategies, processes, standards, test plans, and quality metrics.
• Lead functional, integration, regression, system, and release testing activities.
• Ensure end-to-end traceability between requirements, development, test evidence, defects, approvals, and releases.
• Support and participate in 21 CFR Part 11, HIPAA, GDPR, ISO 27001, information security, vendor, and customer audits.
• Prepare and maintain audit evidence, SOPs, test documentation, quality records, and compliance documentation.
• Identify process gaps and drive CAPA, risk mitigation, and continuous improvement.
• Support audit readiness and ensure timely closure of audit observations and findings.
• Work closely with Development, Product, DevOps, Security, and Project teams to ensure product quality and compliance.
• Review test plans, test cases, automation coverage, defects, test evidence, traceability, and release readiness.
• Establish and continuously improve QA processes aligned with the organization's SDLC and SaaS development practices.
• Mentor and guide QA team members and promote strong quality practices across the organization.
• Ensure production releases meet defined quality, compliance, validation, traceability, and customer expectations.

Required Skills & Experience

• 8+ years of experience in Software Quality Assurance, with experience in a QA Lead or similar senior role.
• Strong understanding of SaaS product development and SDLC processes.
• Experience with vendor audits, customer audits, ISO audits, and information security audits.
• Good understanding of 21 CFR Part 11, HIPAA, GDPR, ISO 27001, data privacy, information security, and compliance requirements.
• Experience generating validation and test packages.
• Experience with quality processes including SOPs, CAPA, risk management, change management, and audit readiness.
• Strong experience in test planning, execution, defect management, and release validation.
• Good understanding of test automation and CI/CD practices.
• Experience working in Agile/Scrum product development environments.
• Strong documentation, analytical, communication, and stakeholder management skills.
• Ability to independently drive QA processes and effectively guide and mentor a QA team.

Preferred Skills

• Experience working in healthcare, clinical, life sciences, or other regulated software environments.
• Experience with Jira, Xray, Playwright/Selenium, Git, and CI/CD pipelines.
• Experience preparing audit evidence and managing audit observations through closure.
• Knowledge of software validation and compliance practices.
• Relevant certifications in QA, ISO 27001, information security, privacy, or compliance would be an advantage.