Senior Software Testing

Remidio; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A medical technology company in Bengaluru is seeking a Lead - Software Testing professional. You will lead software testing activities for medical device software, ensuring compliance with regulatory standards like IEC 62304 and ISO 14971. This role requires strong analytical skills and the ability to document verification and validation processes while collaborating across teams. The position offers a full-time opportunity in the Quality Assurance function within the medical equipment manufacturing industry.

Qualifications

• Review and document test plans in compliance with IEC 62304, ISO 14971, ISO 13485.
• Participate in risk management activities to mitigate software-related hazards.
• Contribute to test documentation for regulatory submissions.

Responsibilities

• Lead software testing activities ensuring compliance with regulatory standards.
• Collaborate with development and QA teams to document verification and validation.
• Support audits and regulatory inspections by providing evidence of testing.

Skills

Manual software Verification & Validation (V&V)

Experience with cybersecurity standards

Risk management (hazard analysis, traceability)

Test planning

Regulatory documentation

Detail-oriented and quality-focused

Strong collaboration and cross-functional communication

Analytical thinking for risk and defect analysis

Proactive in process improvements

Comfortable in regulatory and audit environments

Job description

Join to apply for the Lead - Software Testing role at Remidio

About the Job

Lead software testing activities for medical device software ensuring compliance with regulatory standards like IEC 62304, ISO 14971, ISO 13485, and cybersecurity guidelines. Collaborate across teams to document, verify, and validate software, support audits, and contribute to regulatory submissions.

Technical Skills

• Manual software Verification & Validation (V&V)
• Experience with cybersecurity standards and ISMS documentation (ISO/IEC 27001)
• Risk management (hazard analysis, traceability)
• Test planning, execution, and defect management
• Regulatory documentation

Behavioral Skills

• Detail-oriented and quality-focused
• Strong collaboration and cross-functional communication
• Analytical thinking for risk and defect analysis
• Proactive in process improvements
• Comfortable in regulatory and audit environments

Job Description

• Review, and document test plans, protocols, and reports in compliance with IEC 62304, ISO 14971, ISO 13485, and cybersecurity guidelines.
• Document manual verification and validation (V&V) of software requirements, design, and implementation.
• Ensure proper documentation of testing activities, defect reports, and traceability (requirements → risks → tests → results).
• Participate in risk management activities by identifying, analyzing, and mitigating software-related hazards.
• Prepare Information Security Management Systems and cybersecurity-related documents.
• Work closely with development, QA, and regulatory teams to ensure compliance with regulatory standards (FDA, MDR, IEC 62304, ISO 14971, ISO/IEC 27001, Cybersecurity Guidelines).
• Contribute to test documentation for regulatory submissions (e.g., FDA 510(k), CE marking).
• Support audits and regulatory inspections by providing evidence of testing and risk management activities.
• Participate in continuous improvement of the quality system and test processes.

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Quality Assurance

Industry

Medical Equipment Manufacturing

Location: Bengaluru East, Karnataka, India