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

Positive to Have (Optional - only if mentioned):

As per requirement

Qualifications

BE/BTech

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Tool Validation Engineer Bengaluru (India)
🏢 Proffer IT Consultancy
📍 India