Tool Validation Engineer

Proffer It Consultancy; Bengaluru; On-site; INR 900,000 - 1,200,000; Full time

Job summary

BinQle is seeking a Tool Validation Engineer in Bangalore with 4+ years of experience to validate medical device software and systems in accordance with FDA and ISO requirements.

You will author validation documents, develop IQ/OQ/PQ protocols, perform risk assessments, and ensure traceability and regulatory compliance across QMS frameworks.

Qualifications

• Experience in manual testing.
• Experience in medical device testing.
• Tool validation expertise.
• Experience in the medical/healthcare domain.

Responsibilities

• Author, review, and maintain validation deliverables (URS, FS, DS, Risk Assessments, Validation Plans, Protocols, Traceability Matrices, and Reports).
• Develop, execute, and document IQ, OQ, and PQ protocols for equipment, systems, utilities, software applications, and computerized systems.
• Perform validation activities according to procedures, regulatory requirements, industry standards, and QMS frameworks.
• Conduct risk assessments using risk-based validation and CSA methodologies.
• Develop test protocols, document objective evidence, investigate deviations, and maintain traceability.
• Prepare validation summary reports for release, approval, and change management.
• Assess computerized systems for compliance with electronic records and electronic signature requirements.
• Ensure compliance with FDA 21 CFR Part 11, FDA 21 CFR Part 820, GxP, ISO 13485, ISO 14971, and GAMP 5.

Skills

Manual testing

Medical device testing

Tool validation

Healthcare domain experience

Education

BE/BTech

Job description

Position Name:Tool Validation Engineer

Location:Bangalore

Experience: 4+years

About BinQle

BinQle is a global delivery and execution partner supporting enterprises across the US, India, Singapore and Australia. We specialize in structured hiring, managed teams, and long-term delivery support.

Role Summary

Responsible for performing validation activities, documentation, and compliance assessments for medical devices and related computerized systems. Ensures adherence to regulatory and quality standards within the healthcare/medical domain.

What Youll Do

• Author, review, and maintain validation deliverables including URS, FS, DS, Risk Assessments, Validation Plans, Protocols, Traceability Matrices, and Reports
• Develop, execute, and document IQ, OQ, and PQ protocols for equipment, systems, utilities, software applications, and computerized systems
• Perform validation activities according to approved procedures, regulatory requirements, industry standards, and Quality Management System (QMS) frameworks
• Conduct risk assessments using risk-based validation and Computer Software Assurance (CSA) methodologies
• Develop test protocols, document objective evidence, investigate deviations, and maintain complete traceability
• Prepare validation summary reports for formal release, approval, and change management activities
• Assess computerized systems for compliance with electronic records and electronic signature requirements
• Ensure compliance with FDA 21 CFR Part 11, FDA 21 CFR Part 820, GxP requirements, ISO 13485, ISO 14971, and GAMP 5

What We re Looking For (Must-Haves):

• Experience in manual testing
• Experience in medical device testing
• Tool validation expertise
• Experience in the medical/healthcare domain

Good to Have (Optional - only if mentioned):

As per requirement

Qualifications:

BE/BTech