Aditya Kannan

• Quality Engineer for various Non-med software device for buisness line D&A and helped increasing the release cycle by 40%.

• Responsible for ensuring process compliance for SW medical device development for design and documents review.

• Responsible for Incorporating change to PLM Document Toolchain as part of agile software development which helped releasing the product cycle by 60%

• Supporting projects regarding process and regulatory compliance by working with Quality Manager.

• Successfully help launch New product Development for various medical device.

• Coordinated the team in Germany with QMS requirement to start the project.

• Develop the Measurement System Analysis Plan for the program.

• Involved in various milestone releases for SW medical device product and Versions by coordinating with global team for document review.

• Successfully released various software non-medical device as Quality Manager and recommended key process improvements.

• Perform regular data analysis on defects with disparate data sets using Microsoft Excel functions like (VLOOKUP, data validation) and used Power BI to represent data to management.

•Coordinating Tool transition from JIRA/JAMA to Azure Devops as Quality manager.

• Prepared the team in clearing internal and external audit (MDSAP, Tuev, FDA audit).

• Supporting in obtaining market approvals (such as 510(k), CE marking etc.) by working with Regulatory Affairs Manager.

• Exposure to standards and regulations such as FDA QSR, 93/42/EEC Medical Device Directive (MDD), MDR, ISO 13485, ISO 9001

• Skilled in developing Process flow (SOPs) using Visio and internal tools with compliance with FDA for the Business line and proposed it to peers.

• Supporting in continuous process improvement of Quality Management System.

• Participated in the assessments for the requirements of 21 CFR part 11 and FDA regulations.

• EH&S coordinator for Ann arbor location.

• Annual Reporting for Industrial Environmental Protection Reporting in Global Siemens website.

• Quarterly Compliance Inspection following OSHA, ISO -45001, ISO-14001 for the site

• Supported in ensuring process compliance for SW medical device development e.g. perform design and documentation reviews, support the project regarding process and regulatory compliance by working with Quality Manager.
• Worked on continuous process improvement of Quality Management System.
• Supported the team for Tuev / FDA audit .
• Contributed in obtaining proper market approvals (such as 510(k), CE marking etc.) by working with Regulatory Aff airs Manager.

• Led and contributed in continuous process improvement using Lean tools such as Pareto charts, process flow diagrams, Poka - Yoke and control charts.
• Performed detailed root cause analysis on customer complaints to drive Corrective and Preventive Action (CAPA)improvements.
• Prepared PPAP documents; Control Plan, Flow Charts, Process Drawings, PSW's and PFMEA's.
• Developed 8D reports to customer complaints and initiated containment and corrective actions.
• Identified the bottleneck in Boot press operation and modified the process to improve efficiency of the system.
• Monitored and coordinated with Quality supervisor and Quality inspector on troubleshooting issues related with sorting, inspection and reworking of parts.
• Project Coordinator for a customer with Mold defects on their 8 containers with Automotive parts shipped overseas and Gave solutions to their problem which saved the customer $75,000 USD and potential business with an OEM.
• Managed Gage Calibration Study and trained operators and technicians in using the gage.
• Performed MODAPTS Time study analysis during the new Sorting, inspection or rework activities to achieve Maximum throughput and effective cycle time.
• Worked on requirements of ISO 9001/ IATF 16949 Compliance and assisted with internal audits.