Job Description Position
n Designation: Test Lab Consultant
n Department: Quality / R&D; / Regulatory
n Engagement: Consultant / Part time / Project-based
n Location: Noida / Gurugram, India
n Reporting To: Head – Quality / Operations
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n1. Role Objective
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nThe 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.
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nThe 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 .
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n2. Key Responsibilities
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n A. Test Laboratory Setup & Planning
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Develop the overall test laboratory concept, infrastructure and equipment requirements.n
Prepare a comprehensive Test Laboratory Master Equipment List .n




Define equipment specifications, capacity and performance requirements.n
Recommend suitable test instruments, fixtures, gauges and measurement systems.n
Support vendor identification, technical evaluation and comparison of quotations.n
Define laboratory layout, utilities, environmental requirements and safety provisions.n
Establish requirements for calibration, maintenance and equipment qualification.n

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n B. Medical Device Testing
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nProvide technical guidance for testing of medical devices, including as applicable:
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Electrical safety testingn
EMC testingn
Mechanical and structural testingn
Environmental testingn
Performance and functional testingn
Software / firmware verification supportn
Battery and electrical system testingn
Biocompatibility test coordinationn
Packaging and transportation testingn
Shelf-life and accelerated-aging studiesn
Sterilization-related

📌 Test Lab Consultant Noida
🏢 Shukra Pharmaceuticals
📍 Noida