Lokesh Khurmi

With over 20 years of experience in the medical device industry and manufacturing, I possess a strong knowledge of global medical device regulations, including those in China, Singapore, South Korea, and more. My expertise lies in New Product Development, design controls, risk management (DFMEA, PFMEA), GMP, and ISO 14971. I excel in root cause analysis (8D, 5 Whys), CAPA, validation, and change management. Additionally, I have extensive experience in supplier controls, audits, and quality agreements. My strong leadership and project management skills facilitate effective cross-functional collaboration. I take pride in excellent communication, problem-solving abilities, and a customer service mindset. With high integrity and a strong work ethic, I am adaptable to dynamic environments.

• 2024, Developed a unified Multidivisional Quality Management System (QMS) to optimize multiple QMSs.
• 2022, Represented Stryker in AdvaMed Quality and Inspection Working Group.
• 2019, First assessor at Stryker for Capability Maturity Model Integration (CMMI) under the FDA for Medical Device Discovery Appraisal Program (MDDAP).
• 2018, Global Process Owner (GPO) for the development of a TrackWise audit module eSystem for Stryker.
• 2016, Led a team to develop Medical Device Single Audit Program (MDSAP) at Stryker.
• 2013, Led PPAP committee to standardize the Production Part Approval Process (PPAP).
• 2011, Developed a new product risk management process within the advanced quality group.
• 2009, Created a pre/post supplier audit assessment tool and audit checklist for Stryker.