Position

Designation: Test Lab Consultant

Department: Quality / R&D; / Regulatory

Engagement: Consultant / Part time / Project-based

Location: Noida / Gurugram, India

Reporting To: Head – Quality / Operations

1. Role Objective The 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 Responsibilities

A. Test Laboratory Setup & Planning

- Develop 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 Testing

Provide technical guidance for testing of medical devices, including as applicable:

- Electrical safety testing
- EMC testing
- Mechanical and structural testing
- Environmental testing
- Performance and functional testing
- Software / firmware verification support
- Battery and electrical system testing
- Biocompatibility test coordination
- Packaging and transportation testing
- Shelf-life and accelerated-aging studies
- Sterilization-related testing
- Usability-related verification support
- Reliability and endurance testing
- Risk-control verification testing

The consultant shall identify when testing should be conducted internally versus through NABL-accredited / appropriately qualified external laboratories. C. Standards & Regulatory Compliance

- Identify applicable standards for each medical-device product.
- Develop a Product Testing & Standards Matrix.
- Support interpretation and implementation of applicable:
- ISO standards
- IEC standards
- BIS standards
- CDSCO requirements
- Indian Pharmacopoeia / applicable pharmacopeial requirements
- International standards where applicable
- Review 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 Development

- Develop and review:
- Test protocols
- Test methods
- Work instructions
- Test specifications
- Acceptance criteria
- Test reports
- Verification protocols
- Validation protocols
- Equipment qualification protocols




- Ensure traceability between design inputs → risks → verification requirements → test methods → acceptance criteria → test results.
- Review deviations, failures and out-of-specification results.

E. Laboratory Quality System

Support implementation of laboratory controls including:

- Equipment calibration system
- Preventive maintenance
- Equipment qualification
- Reference standards
- Measurement traceability
- Test sample identification and traceability
- Data integrity
- Test-result review and approval
- Laboratory SOPs
- Environmental monitoring
- Record retention
- Training and competency assessment

Where applicable, support the organization toward ISO/IEC 17025 laboratory requirements.

F. Equipment Qualification

Support qualification of critical test equipment through:

- URS – User Requirement Specification
- DQ – Design Qualification
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- Calibration
- Periodic verification
- Preventive maintenance

G. Failure Investigation & Root Cause Analysis

- Review failed or abnormal test results.
- Lead/support root-cause investigations.
- Use appropriate tools such as:
- 5 Why
- Fishbone Analysis
- Fault Tree Analysis
- FMEA
- DOE, where appropriate
- Recommend corrective and preventive actions.
- Support CAPA implementation and effectiveness verification.

H. External Laboratory Management

- Identify 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 Deliverables The consultant will be expected to deliver, as applicable:

- Test Laboratory Setup Plan
- Laboratory Master Equipment List
- Equipment Technical Specifications / URS
- Product Test Matrix
- Applicable Standards Matrix
- Test Method & Protocol Templates
- Laboratory SOP Framework
- Equipment Qualification Plan
- Calibration & Maintenance Plan
- Internal vs. External Testing Strategy
- Test Report Review Framework
- Laboratory Documentation System
- Testing Cost Optimization Plan
- Laboratory Readiness / Gap Assessment Report
- Support for regulatory and quality audits

4. Qualification & Experience

Education:

- 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 Competencies The consultant should have strong knowledge of:

- Medical-device V&V;
- Design verification and validation
- Test method development
- Risk management – ISO 14971
- Quality management – ISO 13485
- Electrical safety – IEC 60601-1, where applicable
- EMC – IEC 60601-1-2, where applicable
- Software lifecycle – IEC 62304, where applicable
- Usability engineering – IEC 62366, where applicable
- Biocompatibility – ISO 10993 series, where applicable
- Packaging – ISO 11607 series, where applicable
- Environmental and reliability testing
- Calibration and measurement systems
- ISO/IEC 17025 laboratory practices
- Statistical analysis and test-data interpretation

6. Preferred Product Experience

Experience with one or more of the following medical-device categories will be preferred:

- X-Ray / Medical Imaging Systems
- Mobile DR
- Surgical Robotics
- Patient Monitoring Systems
- Infusion / Drug Delivery Devices
- Diagnostic Devices
- IVD Products
- Electromechanical Medical Devices
- Wearable Medical Devices
- Surgical Devices
- Rehabilitation / Assistive Devices

7. 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 Model The consultant may be engaged on a:

- Monthly retainer basis
- Project-based consultancy
- Man-day consultancy
- Laboratory setup assignment
- Product-specific testing assignment

The 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 Profile The 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 (Noida)
🏢 SHUKRA PHARMACEUTICALS
📍 Noida