Krishnakumar Venkadasamy

• Generated technical drawings, assembly instructions and bill of materials. • Troubleshooted existing products in order to identify potential design improvements. • Provided engineering support to production personnel during the manufacturing process. • Interacted directly with customers in order to resolve any issues related to the design of a product.

Implemented Lean Manufacturing Problem Solving Methods to reduce rejections and scraps. Performed Quality Investigation and Implemented CAPA related to production equipment and calibration. Worked on daily tracking and monitoring QMS for change control requests. Understand ISO 13485, 21 CFR Part 820 Quality System Regulations, Medical Device Directive, Canadian Medical Device Regulations, JPAL, and other regulations.

• Collaborated with quality team to ensure standards. • Conducted root cause analysis for faults. • Comply to company policy and ISO 9001 and ISO 14001 requirements. • Adhere to the production plan and conduct the production to accomplish the daily tasks. • Assisting engineers in product development and testing. • Compiling and evaluating statistical data for product quality and reliability