Darshan Sharma
Supplier Quality Engineer at Medtronic | Ex-Philips | Medical device manufacturing | Healthcare
- Role
- Supplier Quality Engineer at 美敦力
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Darshan Sharma
As a Supplier Quality Engineer, I am passionate about achieving high-quality performance…
Experience
Supplier Quality Engineer
May 2024 — Present · Hyderabad, IN
As a Supplier Quality Engineer at Medtronic, I am responsible for leading the Production Part Approval Process (PPAP) process for new product introductions (NPI) and overseeing design changes for existing parts. My role involves managing and supporting Supplier Corrective and Preventive Action (SCAPA) plans to enhance supplier quality performance. I develop and implement processes for both components and finished devices, utilizing Supplier Process Failure Modes and Effects Analysis (pFMEA), Test Method Validation (TMV), Equipment/Installation Qualification (IQ), Operational Process Qualification (OQ), Performance Qualification (PQ), and Lot Traceability Reporting. I am skilled in creating Supplier Process Control Plans and reviewing protocols for Gage Repeatability and Reproducibility, Test Method Validation, and Installation/Operational Qualification Reports. My responsibilities also include conducting Minitab Analysis and determining Sample Size Plans. I actively contribute to internal audits to ensure compliance with ISO 13485 standards and prepare receiving inspection requirements and associated test method validations for internal Medtronic Test Methods. My role is pivotal in ensuring that purchased products and components adhere to industry standards, regulatory requirements, and customer specifications.
Education
Dr. D. Y. Patil Institute of Engineering & Technology, Pune
Bachelor of Engineering, Mechanical Engineering
2015 — 2019
Birla Institute of Technology and Science, Pilani
Master of Technology - MTech, Quality Management System
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