Kirit Patel

Background

About Kirit Patel

Accomplished and collaborative Principal Engineer delivering the principles of Quality Engineering, Supplier Quality Engineering, and Manufacturing In-Vitro Diagnostic Medical device, life science and industrial manufacturing for the global companies. • Strong direct experience and a successful record with the development and implementation of quality system processes in controlled medical systems. • Accustomed to a demanding / fast paced / dynamic environment, as well as handling multiple projects simultaneously while maintaining a solid business focus. • Deliver high-quality systems and consistently exceed internal & external customers and user satisfaction. • Ability to mitigate and reduce risks throughout project phases while implementing long-term best practice strategies and to meet quality standards. • Provide product quality technical discipline to the suppliers / CMs. • Work cross-functionally on continuous improvement products / processes by analytically and best practices. • Excellent Soft Skills – Flexible, Collaborate, Problem-solving, Adaptability, Attention to details, Creative, Teachable, Communication (written / verbal), consider human factors, Mentoring. • Experienced working with large corporations and smaller privately owned start-up organizations. • U.S. Citizen. Key Areas of Expertise / Knowledge / familiar (Medical Device, Life Science, and Industrial manufacturing) • Knowledge on ISO 9001, 13485, & 14971, 21CFR820, and MDSAP. • Risk analysis by Process Flow Chart, Control Plan & PFMEA. • Supplier’s strategy - new & current. • Supplier Quality performance. • Supplier Quality processes. • 3PL Implementation (A-Z). • QMS – Standards, CAPA, deviation, NC, MRB, Audits, and SCARS. • Auditee – Compliance / Customer. • Auditor – Internal / Supplier. • Statistical Analysis. • Analytical skills – quality tools. • Validation of OEM Injection molding IQ, OQ, PQ, FAT, SAT. • OEM Quality Master Validation Plan. • Validation – PCBA / Box build. • QA - Improve Process / Procedure. • QC – Focus on product quality. • CAPA – root cause analysis, CA/PA verification, technical support. • Continuous improvements by Kaizen, DMAIC, PDCA, A3. • Enterprise systems – PLM, LMS. • Understand engineering drawing. • Mentoring / leadership to junior engineers, technicians. • Provide in-house training, ASQ certs – CSSGB, CQT & CQI.