Pradeep Kumar Rajkumar Email & Phone Number

A Graduate student from the Department of Biomedical Engineering at San Jose State University. I am interested to work with quality and regulatory teams in a Medical Device or Pharmaceutical Industry. I have taken up various courses such as Regulatory, Clinical and Manufacturing Aspects of Medical Devices, Biomedical Device Manufacturing, and Biomedical Device Design and Principles at San Jose State University which helped me understand the industry needs and skills to work as a Quality or Regulatory Engineer.I have previously worked at a Medical Device firm where I developed a prototype of a Non-Invasive Glucometer. During my term, I developed Project Plans, Standard Operating Procedures (SOP's), Failure Mode and Effect Analysis (FMEA's), and Biocompatibility Plans. I also adhered to Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) and maintained documents, records, and spreadsheets required by the company in compliance with ISO 13485, ISO 14971, 21 CFR Part 820. My core competencies include:Quality: Certified Six Sigma Green Belt, ISO 13485, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Failure Mode Effect Analysis (FMEA), Gauge R&R, Pareto Analysis, DMAIC, DFSS, Total Quality Management, Implementation of Quality Management System (QMS), and Documentation of Agreements, Storage of Supplies and Purchasing Reports.Risk Management: ISO 14971, Development of Risk Management Plan, Failure Mode and Effect Analysis (FMEA), Corrective Action and Prevention Action (CAPA), and Fishbone Diagram.Documentation: Development of test protocols, Test Cases and Test Scripts, Standard Operating Procedures, Instruction for Use, Specification Documents, and Reports.Statistical Tools: Minitab, Microsoft Excel, Matlab, and Python.Regulatory: Design Control Process, FDA Approvals, New Drug Application (NDA), European Medical Device Regulations (EU MDR), Medical Device Single Audit Program (MDSAP), 510k Submissions, Instruction for Use (IFU.) Certifications: Certified Six Sigma Green Belt, European Medical Device Regulations (EU MDR), ISO 13485: Quality Management, ISO 14971: Risk Management, TQM, and Minitab.In addition to the above skill set, I am an enthusiastic individual with a team player attitude and good communication skills. I have a great capability to lead projects and manage teams, where I've organized multiple national events and projects.If you need any additional information or if there are any positions that I would be a good fit for please do reach out to me on rpkumar0407@gmail.com.

Listed skills include Leadership, Test Scenarios, Research And Development, Public Speaking, and 29 others.