Sumeet P

About Sumeet P

Result-driven individual with experience in Quality Engineering and Regulatory Compliance…

Experience

1. Sr Design Quality Engineer - Igt Systems

   Philips

   Sep 2023 — Present · Pune, IN

   Responsible for the design control in Sustaining Project/lifecycle management Quality Assurance.• Defining and review quality and regulatory requirements for the product within design process.• Ensure product-development processes and documentation meet Quality System requirements in relevant regulations, e.g. 21 CFR 820.30, ISO13485. • Drive project decision direction toward compliance, cross functionally.• Ensures the DHF is adherent to the required processes & compliant throughout the project’s Product Realization Process phases as documented in Project Plan.• Key member of product defect management board, engineering change board.(Product)• Expert of design control and lead Design Control process improvement.• Participation in the decision-making process of product-quality related decisions.• Lead, prepare and participate in internal and external audits• CAPA Facilitation for design control related nonconformance.• Involve in driving Quality metrics like Cost of Non-Quality, Productivity, Defect Density etc. and measurable improvements that are required to meet quality system standards. Creating and maintaining monthly trending of the Metrics.• Effectively supported FDA fore cause inspection at backroom audits by collaborating with audit personnel and providing comprehensive assistance throughout the audit process. Leveraged expertise to address audit findings and formulate corrective action plans for further improvements.• Quality Lead for RFS CCB to review the ongoing design changes & field changes, OCCB Handshake meeting to ensure proper handover of Design transfer to operation, managing the review and release of Design change implementation and managing field tailored request for released system configurations.