Chidambaram Sankarapandi

Quality Lead @Wipro

Bengaluru, IN

Served as liaison to Notified Body inspectors during external audit at the site. Preparing the audit schedule and informing the team member about the audit schedule, conducting the internal audit. Support in the creation and maintenance of training materials.Responsible for collaborate with the relevant team leads of projects and other functions to stay aligned in QMS harmonization/alignment efforts. Performed QMS gap analysis and implementation of improvements to align on regulatory/standard changes compliance. Keeping up to date on applicable FDA, EUMDR, and ISO13485. Continuous improvement by implementing lean and six sigma for the projects. Review of Quality data from multiple quality systems and processes for timely reporting of quality system performance to management, including, but not limited to: Project data metrics repot, CAPA performance, Training compliance, Audit action monitoring and process adherence, supplier management and monitoring. Preparing training compliance reports on weekly basis and publishing to the team and encourage the team to take the training course. Work with CAPA owners to maintain CAPA program in a proper and efficient manner.Performing root cause analysis using 5 why and fish bone techniques for the issues reported. Creation and maintenance of quality plan based on the nature of the project. Monitor the Risk mitigation process and ensure the risk mitigation is implemented on timely manner.

Madurai Kamaraj University

Bachelor's degree

DR M.G.R university

Master of Technology (M.Tech.)

Bharathidasan University, Tiruchirappalli

Master's degree

St.marys higher secondary school

Maths biology