Job Description Summary

The incumbent will join the lab team to provide support to a large cross-functional team. The associate work with moderate level of supervision for medium complex projects. The associate will work on receipt, preparation, testing, and delivery of test samples and support materials for all V&V lab associate testing. They are also responsible for the ordering and stocking of lab supplies and stock inventory of consumables and chemical Inventories. The individual will need to take care of any biological & sharps disposal management. The associate will also involve in execution of continuous improvement projects for the V&V Lab. He / She will serve as the primary reviewer of test requests to ensure accurate completion.

Job Description

• Assists in the generation and execution of formal test protocols and reports.
• Sets up and operates test equipment and records measurements with limited supervision.
• Manages testing of released protocols, including insuring adequate test material inventory and reports on a project level.
• Executes Continuous Improvement projects in the following (but not limited to) areas:

o Equipment or method troubleshooting/repairs.

o Coordinates with Test Method Development and Verification & Validation team for equipment and method validations

o Method or Equipment Upgrades

o Fixture maintenance

o Drawing or Specification modifications

• The incumbent will also work with the team on product failure, defect management and CAPA investigations.
• Assists in statistical analysis of data.
• Maintain an R&D Laboratory Notebook
• Coordinates Calibration / Preventive Maintenance / repair schedule and documentation
• Maintains the Tool Crib and Fixture inventory.
• Manages the chemical inventory and Medical Safety Data Sheets (MSDS) upkeep. Ensures timely removal of expired chemicals.
• Responsible for assisting in evaluation of new products, materials / technologies, and non-conforming product investigations.
• Provides process/test method training to Manufacturing/QC personnel and other technicians.
• Develops and maintains a working knowledge of BD policies and procedures aligned with ISO and FDA requirements.
• Must be able to work in a bio-hazard environment and comply with safety policies and procedures outlined by BD policies.
• Support internal / external audit requirements for Lab

Education:

Diploma in Engineering [Mechanical / Electrical / Electronics / Instrumentation]

Experience:

7 - 12 years’ experience in medical device or other regulated industry labs.

Knowledge:

o Standard laboratory practices.

o Data collection, management, and analysis

o Inventory management

o Basic of statistics

o Lab maintenance

o Quality Inspection techniques

o Vendor management

o Medical Regulatory Standards

Skills:

o Technical Writing

o Good communication skills (written/verbal)

o Equipment Programming

Primary Work Location

IND Bangalore - Technology Campus

Additional Locations

Work Shift