Hardik L.

About Hardik L.

Certified Lean Six Sigma professional and high-performing mechanical engineer with 3+…

Experience

1. Staff Quality Engineer - Npi Lcm

   Johnson & Johnson

   Feb 2022 — Present

   Utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. • Utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision.• Utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.• Function as the Quality representative in new product development and lead in efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and statistical process control. • Develop a comprehensive risk management plan and ensure the delivery and utilization of effective quality strategies through all aspects of Design Control and Life Cycle Management of the product. • Ensure compliance with company policies and procedures while providing mentorship in the implementation of regulatory requirements (e.g, Quality System Regulation, EU MDD, ISO standards, etc.). • Assist the team to ensure the application of design controls and product risk management as well as the investigation/correction of design failures/challenges and effective design control and transfer. • Collaborate with Manufacturing Quality Engineering to implement and supervise process capability measures prior to Design transfer.• Provide Lifecycle Management Support by providing accurate review and direction during change control and continuous improvement activities for changes that could affect the product design (form, fit, function and labeling requirements). • Ensures consistent application of Quality Engineering, Process Excellence/Six Sigma tools and techniques, including active and detailed investigation of quality issues and effective corrective and/or preventive action.