Job Type: Part time

PositionDesignation: Test Lab ConsultantDepartment: Quality / R&D; / RegulatoryEngagement: Consultant / Part-time / Project-basedLocation: Noida / Gurugram, IndiaReporting To: Head – Quality / Operations1. Role ObjectiveThe Test Lab Consultant will be responsible for providing technical and strategic guidance for the planning, establishment, qualification, operation, and continuous improvement of testing laboratory facilities for medical devices.The consultant will support the organization in defining appropriate test methods, selecting test equipment, developing test protocols, evaluating external and internal laboratory capabilities, and ensuring that testing activities comply with applicable ISO, IEC, BIS, CDSCO and other relevant regulatory requirements.2. Key ResponsibilitiesA. Test Laboratory Setup & PlanningDevelop the overall test laboratory concept, infrastructure and equipment requirements.Prepare a comprehensive Test Laboratory Master Equipment List.Define equipment specifications, capacity and performance requirements.Recommend suitable test instruments, fixtures, gauges and measurement systems.Support vendor identification, technical evaluation and comparison of quotations.Define laboratory layout, utilities, environmental requirements and safety provisions.Establish requirements for calibration, maintenance and equipment qualification.B. Medical Device TestingProvide technical guidance for testing of medical devices, including as applicable:Electrical safety testingEMC testingMechanical and structural testingEnvironmental testingPerformance and functional testingSoftware / firmware verification supportBattery and electrical system testingBiocompatibility test coordinationPackaging and transportation testingShelf-life and accelerated-aging studiesSterilization-related testingUsability-related verification supportReliability and endurance testingRisk-control verification testingThe consultant shall identify when testing should be conducted internally versus through NABL-accredited / appropriately qualified external laboratories.C. Standards & Regulatory ComplianceIdentify applicable standards for each medical-device product.Develop a Product Testing & Standards Matrix.Support interpretation and implementation of applicable:ISO standardsIEC standardsBIS standardsCDSCO requirementsIndian Pharmacopoeia / applicable pharmacopeial requirementsInternational standards where applicableReview test reports for adequacy and regulatory acceptability.Support preparation of technical documentation and Design Dossiers / Technical Documentation.Provide technical inputs during regulatory audits and inspections.D.



Test Protocol & Report DevelopmentDevelop and review:Test protocolsTest methodsWork instructionsTest specificationsAcceptance criteriaTest reportsVerification protocolsValidation protocolsEquipment qualification protocolsEnsure traceability between design inputs → risks → verification requirements → test methods → acceptance criteria → test results.Review deviations, failures and out-of-specification results.E. Laboratory Quality SystemSupport implementation of laboratory controls including:Equipment calibration systemPreventive maintenanceEquipment qualificationReference standardsMeasurement traceabilityTest sample identification and traceabilityData integrityTest-result review and approvalLaboratory SOPsEnvironmental monitoringRecord retentionTraining and competency assessmentWhere applicable, support the organization toward ISO/IEC 17025 laboratory requirements.F. Equipment QualificationSupport qualification of critical test equipment through:URS – User Requirement SpecificationDQ – Design QualificationIQ – Installation QualificationOQ – Operational QualificationPQ – Performance QualificationCalibrationPeriodic verificationPreventive maintenanceG. Failure Investigation & Root Cause AnalysisReview failed or abnormal test results.Lead/support root-cause investigations.Use appropriate tools such as:5 WhyFishbone AnalysisFault Tree AnalysisFMEADOE, where appropriateRecommend corrective and preventive actions.Support CAPA implementation and effectiveness verification.H. External Laboratory ManagementIdentify and technically evaluate external testing laboratories.Review laboratory accreditation and scope.Prepare RFQs and technical test requirements.Evaluate quotations and testing proposals.Coordinate testing schedules and sample requirements.Review external test reports for completeness and compliance.Maintain an approved external laboratory list.3. Key DeliverablesThe consultant will be expected to deliver, as applicable:Test Laboratory Setup PlanLaboratory Master Equipment ListEquipment Technical Specifications / URSProduct Test MatrixApplicable Standards MatrixTest Method & Protocol TemplatesLaboratory SOP FrameworkEquipment Qualification PlanCalibration & Maintenance PlanInternal vs. External Testing StrategyTest Report Review FrameworkLaboratory Documentation SystemTesting Cost Optimization PlanLaboratory Readiness / Gap Assessment ReportSupport for regulatory and quality audits4. Qualification & ExperienceEducation:B.E./B.Tech/M.Tech in Mechanical, Electrical, Electronics, Biomedical, Instrumentation, Medical Engineering, or related discipline.Additional qualification in Quality,



Regulatory Affairs or Testing will be an advantage.Experience:Typically 10–15+ years of relevant experience in medical-device testing, product verification/validation, laboratory management or quality engineering.Strong experience with medical-device testing and applicable international standards.Experience in setting up or managing testing laboratories is highly desirable.Experience with CDSCO submissions and technical documentation will be preferred.Experience working with NABL / ISO/IEC 17025 laboratories will be an advantage.5. Technical CompetenciesThe consultant should have strong knowledge of:Medical-device V&VDesign; verification and validationTest method developmentRisk management – ISO 14971Quality management – ISO 13485Electrical safety – IEC 60601-1, where applicableEMC – IEC 60601-1-2, where applicableSoftware lifecycle – IEC 62304, where applicableUsability engineering – IEC 62366, where applicableBiocompatibility – ISO 10993 series, where applicablePackaging – ISO 11607 series, where applicableEnvironmental and reliability testingCalibration and measurement systemsISO/IEC 17025 laboratory practicesStatistical analysis and test-data interpretation6. Preferred Product ExperienceExperience with one or more of the following medical-device categories will be preferred:X-Ray / Medical Imaging SystemsMobile DRSurgical RoboticsPatient Monitoring SystemsInfusion / Drug Delivery DevicesDiagnostic DevicesIVD ProductsElectromechanical Medical DevicesWearable Medical DevicesSurgical DevicesRehabilitation / Assistive Devices7. Key Performance Indicators (KPIs)Laboratory setup completed as per approved timeline.Testing equipment specification and procurement support.Percentage of tests successfully completed according to approved protocols.Reduction in external testing dependency and cost where technically/regulatorily appropriate.Test-report quality and regulatory acceptance.Calibration compliance.Laboratory audit readiness.Timely closure of test failures and deviations.Traceability and completeness of verification documentation.8. Engagement ModelThe consultant may be engaged on a:Monthly retainer basisProject-based consultancyMan-day consultancyLaboratory setup assignmentProduct-specific testing assignmentThe initial engagement may focus on laboratory gap assessment, test-equipment planning, standards mapping and development of the internal testing framework, followed by implementation support.9. Ideal Candidate ProfileThe ideal candidate should be a hands-on medical-device testing and laboratory expert, capable of translating regulatory and product requirements into practical test methods and laboratory capabilities.The candidate should be comfortable working with R&D;, Quality, Regulatory, Manufacturing and Engineering teams and should be able to independently identify testing gaps, define requirements, review test results and guide the organization toward a robust and audit-ready test laboratory.

📌 Test Lab Consultant – Medical Devices (Ghaziabad)
🏢 SHUKRA PHARMACEUTICALS
📍 Ghaziabad