Laxman Kumar S

Experienced Quality Management Professional with a proven track record of executing successful supplier quality initiatives and process improvements. Proficient in implementing lean and six sigma methodologies to enhance efficiency and elevate quality standards. Adept at evaluating supplier capabilities for regulatory compliance and driving continuous improvement in accordance with ISO and FDA requirements.

Skilled in managing change requests, conducting audits, and collaborating with cross-functional teams to achieve organizational goals. Committed to maintaining the highest quality standards while optimizing processes for superior outcomes.

• Executed supplier quality projects utilizing project management tools, encompassing supplier change requests, process improvements, new supplier qualification, and receiving inspection.
• Implemented lean and six sigma methodologies to drive process and product variance reduction, resulting in increased efficiency and elevated quality standards.
• Conducted assessments and audits to evaluate supplier capability in meeting Procept and regulatory requirements, ensuring compliance with FDA Quality System Regulation, ISO standards, and medical device directives.
• Successfully implemented Supplier Change Requests, effectively managing changes while minimizing disruptions to the supply chain.
• Generated periodic reports on supplier performance, including scorecards, and conducted regular reviews with suppliers to discuss performance, maintenance, and improvement plans.
• Actively participated in failure investigations, analyzing internal system or process failures, and executing corrective and preventive actions.
• Contributed to the continuous improvement of business processes and tools, driving efficiency and enhancing quality across the organization.
• Coordinated Material Review Board (MRB) activities to assess potential non-conforming products promptly, facilitating effective decision-making.
• Supported continuous product and process improvement through meticulous failure analysis, devising and implementing compliant solutions for product and process corrections, retrospective actions, and preventive measures.

Northeastern University, Boston, MA

Master of Science in Mechanical Engineering