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 verificatio

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