Sachin Lapani
Sr Engineer i, Supplier Quality @Terumo Cardiovascular
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WORK HISTORY
Sr Engineer i, Supplier Quality @Terumo Cardiovascular
Ann Arbor, MI, US
Terumo Cardiovascular & its subsidiary Terumo Heart, Inc. is dedicated to the development, production, and advancement of sophisticated electromechanical medical device/products to improve the quality of life of Heart patients. THI developed and launched the Next Generation Intravascular Dual sensor Imaging System for global markets. • Responsible for investigating, planning and implementing improvements in and/or additions to current or potential products, processes and supplier relationships. •Responsible for coordinating with suppliers and material logistics teams in material handling to ensure continuous flow of good quality parts to manufacturing lines. Also performs audits of current and potential suppliers to report findings and recommendations to management.•Performs supplier audits (ISO9001:2015 & ISO13485:2016 including Production readiness) and develops test methods and/or procedures.•Maintains and follows proper ISO procedures to meet FDA and global regulatory requirements.•Ensures that suppliers understand THI’s selection requirements and proposed product specifications. Evaluates suppliers\' capability to reliably supply products or components to THI’s specifications. Provides feedback to THI engineering regarding suppliers\' concerns. Makes recommendations for supplier approval status.•Supports execution of supplier audit plan; performs functions of lead auditor with emphasis on suppliers’ production processes and controls.•Coordinates product and process qualifications with suppliers. Defines FAI requirements.•Engages suppliers to resolve product issues. Coordinates with suppliers to contain significant quality issues and resolve supplier non-conformances.•Facilitates evaluation of supplier-initiated changes such as change in manufacturing location, materials, tooling, or other significant process change.•Provides input into risk management system, DFMEA, PFMEA, etc.•Supports NCMR, CA/PA.•Leading APQP and Coordinating PPAP.
EDUCATION
University
Bachelor of Engineering (B.Eng.)
University
MBA
ABOUT SACHIN LAPANI
Professional Summary:• Passionate and resourceful Quality Engineer with a Bachelor & Master degree and 22 Years of practical diversified experience dedicated to work in Challenging and responsible leadership Quality engineering positions, checking Manufacturing Support to apply intensive knowledge of Quality engineering principles and practices to reach the necessary objectives, or position that utilizes my technical background in Quality Control development. • 1 yr of experience as Sr. Engineer I, Supplier Quality in development, production, and advancement of sophisticated electromechanical medical device/products to improve the quality of life of Heart patients.• 5 yrs. of experience with Tier 1 automotive supplier (NSK) as Sr. Advanced Supplier Quality Engineer in Steering Division (Automotive Products)• 1.5 yrs. of Experience in NVH Products• 9 Years of Experience in PCB Manufacturing Technologies• 3 Years of Experience in PCB Assembly Industries• 3 Years of Experience in Medicine manufacturing IndustriesEmployment History:• NSK North America Steering Systems Americas (NSSA), Ann Arbor, MI, USA; Jan 2017 - August 2021• Roush Industries, Livonia, MI, USA;Sept 2015 -January 2017• Saturn Electronics Corp, Romulus, MI, USA; Jan 2007 - August 2015• Shanti Engerprise, Surat, Gujarat (INDIA); Aug 2003 – Nov 2006• Ban Labs Ltd, Rajkot, Gujarat (INDIA); June – August 2003
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