Akash Panchal

About Akash Panchal

Experienced Quality Engineer with a demonstrated history of working in the medical device industry. Skilled in AutoCAD, SolidWorks, Mechanical Engineering, Performance Management, and Customer Service. Strong arts and design professional with a Master\'s degree focused in Mechanical Engineering from California State University-Los Angeles.

Experience

1. Principal Quality Engineer

   Schuremed

   Mar 2023 — Present · Abington, MA, US

   Accountable for oversight and compliance of the Quality Management System.• Responsible for creating and maintaining cGMP documents and records, including batch production records, validation protocols/reports, product release documentation, change controls, deviations, CAPA, complaint investigations, product quality review, quality agreements, etc.• Responsible for leading Management Review meetings and reporting the performance and effectiveness of the Quality System, as well as any improvements needed, for periodic review and analysis.• Support incoming (receiving & inspection), in-process inspection, final inspection, and product release activities for all manufacturing programs.• Ensure establishment and maintenance of site registrations (e.g, ISO 13485 and FDA).• Primary contact with regulatory agencies for global product registrations.• Responsible for validation planning and its execution according to national and international requirements.Create and maintain CE Mark documentation to ensure MDR and MDD compliance.• Manages FDA submissions, including Pre-Sub meeting planning and follow ups. Author, review and/or approve documentation for process and design change activities as well as validation / verification oversight and/or test method execution in cooperation with cross-functional engineering teams per project requirements.• Authoring and/or approving regulatory documentation including SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.Initiate and/or collaborate in the generation/update of process / product Risk Management documentation, e.g, FMEAs and Hazard Analysis, in collaboration with cross-functional engineering teams.• Manages the review and final approval process of all product advertising and labeling to determine compliance with global labeling requirements.• Primary lead for external regulatory, certification, and customer audits.

Education

• Gujarat Technological University

  Bachelor's degree, Mechanical Engineering

  2009 — 2013

• California State University, Los Angeles

  Master's degree, Mechanical Engineering

  2015 — 2016