Quality Assurance Manager
Current
Mar 2022 - Present
Who is Pradeep Kumar Rajkumar? Overview
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Quick answer
Pradeep Kumar Rajkumar is listed as Quality Assurance Manager at IncellDx, based in San Jose, California, United States. AeroLeads shows a matched LinkedIn profile for Pradeep Kumar Rajkumar.
Pradeep Kumar Rajkumar previously worked as Quality Assurance Specialist at Incelldx and Document Control Specialist at Incelldx. Pradeep Kumar Rajkumar holds Master'S Degree, Biomedical/Medical Engineering from San José State University.
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IncellDx
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Profile bio
About Pradeep Kumar Rajkumar
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.
Current workplace
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9 roles
Pradeep Kumar Rajkumar work experience
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Quality Assurance Specialist
Jul 2021 - Mar 2022
Document Control Specialist
May 2021 - Jun 2021
Document Control Specialist
Mar 2021 - May 2021
Teaching Assistant
Assisted the professor with teaching activities, conducted labs, graded reports, and presentations for the subjects Biomedical Regulatory Affairs, Biomedical Device Design, and Physiology for Engineers.
Aug 2019 - May 2021
Quality And Regulatory Intern
Oct 2020 - Mar 2021
Associate Software Engineer
Worked in the Testing stream and my responsibilities included the following:1. Authored Software Tests and Design Verification and Validation deliverables which included Plan, Requirements, Test Plan, Test Scripts, Test Cases, Design, Protocols, Defect Tracking, PN logging, Traceability Matrix, and Reports.2. Collaborated with Project Management to support the Design Control and SW Development Processes.3. Established testing protocols in the Agile Testing Environment, working with the onshore development teams.
Nov 2017 - Nov 2018
Quality And Design Intern
1. Diploma in 3D printing.2. Designed, Developed, and Engineered a Mechanical Prosthetic Arm.
Jun 2017 - Aug 2017
Research Development Quality Assurance Intern
Designed and developed a prototype of a Non-Invasive glucometer.My responsibilities included:1. Collaborated with a team of doctors and engineers to develop an idea for the design and the functionality of the device.2. Developed and implemented quality standards and quality control systems in the R&D and manufacturing unit.3. Prepared technical documentation, which included manufacturing instructions, test methods, protocols, and reports, to support design control activities and regulatory submissions in compliance to ISO 13485.4. Supported processes such as Document Control, nonconformances, CAPAs, and developing of Quality metrics.5. Assisted with Design Controls guidance in regards to User Needs, Design Input and Outputs, Design Verification and Validation, Risk Management, Design Transfer, Design Reviews, and Product Lifecycle Management. 6. Collected and analyzed process defect data for product/process improvement efforts by gathering quality metric data and performing the appropriate analysis methods to enhance sustaining product design.7. Assisted with Risk Management Activities for complex systems in compliance with ISO 14971 and IEC 62304.8. Ensured production process activities are in compliance with Quality System, FDA QSR, MDD, and ISO 13485.9. Maintained Spreadsheets, Managed Databases, and updated the supervisor with the current status of the project and areas needed for improvement to follow good quality procedures. 10. Wrote Standard Operating Procedures (SOP’s) and operating manuals related to the design, development, and operating of the device following Good Documentation Practices adhering to the 21 CFR 820 of the FDA.
May 2016 - May 2017
2 education records
Pradeep Kumar Rajkumar education
Master'S Degree, Biomedical/Medical Engineering
San José State University
Bachelor’S Degree, Medical Electronics
B. M. S. College Of Engineering
FAQ
Frequently asked questions about Pradeep Kumar Rajkumar
Quick answers generated from the profile data available on this page.
What company does Pradeep Kumar Rajkumar work for?
Pradeep Kumar Rajkumar works for IncellDx.
What is Pradeep Kumar Rajkumar's role at IncellDx?
Pradeep Kumar Rajkumar is listed as Quality Assurance Manager at IncellDx.
Where is Pradeep Kumar Rajkumar based?
Pradeep Kumar Rajkumar is based in San Jose, California, United States while working with IncellDx.
What companies has Pradeep Kumar Rajkumar worked for?
Pradeep Kumar Rajkumar has worked for Incelldx, San Jose State University, Equilibrium By Vayu Technology, Accenture, and 3Dexter.
How can I contact Pradeep Kumar Rajkumar?
You can use AeroLeads to view verified contact signals for Pradeep Kumar Rajkumar at IncellDx, including work email, phone, and LinkedIn data when available.
What schools did Pradeep Kumar Rajkumar attend?
Pradeep Kumar Rajkumar holds Master'S Degree, Biomedical/Medical Engineering from San José State University.
What skills is Pradeep Kumar Rajkumar known for?
Pradeep Kumar Rajkumar is listed with skills including Leadership, Test Scenarios, Research And Development, Public Speaking, Iso 14971, Failure Mode And Effects Analysis, Gmp, and Matlab.
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