Tool Validation Engineer
Proffer It Consultancy · Bengaluru · onsite · Posted 21d ago
Undisclosed4–9 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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
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.
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
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.
Sourced from naukri
Skills
AssuranceISO 13485application softwareChange ManagementDevice Testingquality standardsHealthcaremanual testingQMSMedical Devices