Khush Patel Email & Phone Number

Germantown, Md, United States

Manage compliance to FDA quality system regulations, ISO 9001/13485 requirements.Responsible for processing complaints and when necessary (MDR, Vigilance) reports.Manage manufacturing validations which include the development of and authoring protocols, working with operations to execute activities, perform analysis and write reports.Manage and/or participate in CAPA process to resolve manufacturing related issuesWork with cross-functional teams to identify and implement process improvements for existing products.Participate in complaint investigations.Coordinate and lead the Material Review Board for evaluation and investigation of non-conforming material.

Mississauga

Planning, implementing and co-ordination of product development to include: product design, product specifications, process validations, identification of training needs, process & equipment lay-out, production procedures, material specifications, material & packaging procurement.Design and introduce manufacturing processes for products to increase capabilities and efficiencies delivering a competitive edge to our company and our customers.Apply structured problem solving, lean principals, and best practice process development to drive product and process improvements.

Sudbury, Canada

Assisted in troubleshooting, determination of root cause and implementation of permanent corrective measures in a lab, located 6800 ft underground, to help pursue the search for neutrinoless double beta decay.Execute complex sequences of procedures for the purpose of process test/validation. Collected data and analyzed various parameters inside the chemical plant, while presenting conclusions coherently.Created and modified PID controller tuning of various pumps and instrumentation, to ensure various parameters for the processes were met without human interaction.

Ontario, Canada

Assisting project managers and designers by designing sub-assemblies of transfer machinesUsing GD&T standards to send welders detail drawings to fabricate composite componentsCreating and assembling various documentations for engineers, project managers, customers and the production team

Ontario, Canada

My responsibilities were, but not limited to:Creating models of various parts for CNC Machines on CAD programs, primary on SolidWorks & AutoCAD, to show Sr. Engineers for approval to build prototype and test functionality on test machines.Put in charge of creating a schedule to run the engineering cut shop and operate the CNC Machine to ensure all parts that were required to be cut on the rmachines were received before the project deadline.Used ArtCAM to convert SolidWorks or AutoCAD files to CNC language.Made reports such as, manufacturing procedures, manuals, ECN's, EAN's and Bill of Materials.Designing and editing new/old fixtures of CNC Machines.Ensured parts sent out for painting or welding were received on time.

Toronto, Canada Area

My responsibilities alternated depending on if I was the guard or the screener. As I guard I had to ensure the premises were secured and no one suspicious tried to intrude the premises. I had to maintain order inside the grounds and write daily reports on how the day went and report any suspicious activity.As a screener, I had to screen 100's of visitors, athletes and employees to make sure unwanted items didn’t enter the premises to protect the lives of everyone inside the grounds on a daily basis.

Master'S Degree, Systems Engineering

Bachelor’S Degree, Mechanical Engineering

Activities and Societies: Intramural Soccer and Volleyball