Document Control Quality

Pradeep Kumar Rajkumar

adkeux@r.postjobfree.com 669-***-**** San Jose – 95112 www.linkedin.com/in/pradeepkumar-rajkumar/

EDUCATION:

M.S. in Biomedical Engineering at San Jose State University, CA GPA - 3.70/4.0 Jan 2019 – May 2021

B.S. in Biomedical Engineering at BMS College of Engineering, India GPA - 3.66/4.0 Aug 2013 – May 2017

CORE COMPETENCIES:

Quality: ISO 13485, Six Sigma Green Belt, Root Cause Analysis, Verification and Validation, CAPA, FMEA, IFU, GCP/GMP, Design Control, Document Control, Lean Manufacturing.

Regulatory: EU MDR, 21 CFRs, 510(k), PMA, IEC 62304, IEC 60601, IDE, MDD, Risk Analysis, ISO 14971, ISO 10993, FDA

Technical Skills: Machine Learning, 3D Printing, Automation Testing, Medical Device Development, Product development

Computer Skills: Python, MATLAB, Java, Microsoft Office, GraphPad PRISM, Minitab, KeilVision

Interpersonal Skills: Leadership, Good communication skills, Public speaking, Attentive to Details, Team player

WORK EXPERIENCE:

Quality and Regulatory Intern, Vayu Technology Oct 2020 – Present

Worked cross-functionally with Engineering, Quality and Regulatory teams to develop and implement quality standards and

quality control systems (QMS) required for the company and the product to receive an FDA approval.

Ensured that workflows, processes in the company, and product comply with the ISO 13485 and FDA regulations.

Researched and developed regulatory pathway and procedures to bring a class II device to the market.

Assisted the various teams in documentation of the test reports, SOPs, Protocols, Design History Files and regulatory filing.

Teaching Assistant, San Jose State University Aug 2019 – Present

Conducted lectures, graded reports, presentations and assisted students with experiments performed in the lab.

Developed material and conducted lectures on QA, RA and covered topics such as QMS, Risk Analysis and Design Control.

Associate Software Engineer, Accenture Nov 2017 – Nov 2018

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 for the testing team.

Collaborated with Project Management teams to support the Design Control and SW Development Processes in the units.

Established testing protocols in the Agile Testing Environment, working with the onshore development teams.

Validation – Quality Intern, Organization De Scalene May 2016 - May 2017

Developed and implemented quality standards and quality control systems for R&D and Manufacturing units.

Authored documents which included manufacturing work instructions, test methods, and validation protocols.

Supported processes such as Document Control, Corrective Action (CAPA), and developing of Quality metrics.

Assisted the team with Design Controls in regards to Design Verification, Validation, and Product Lifecycle Management.

Collected and analysed process defect data for product/process improvement efforts by gathering quality metric data and performing the appropriate analysis methods (ANOVA, GAP, Gage R&R) to enhance product design.

Assisted with Risk Management Activities and performed FMEA in compliance with ISO 14971 and IEC 62304.

Ensured Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) in the manufacturing unit.

Analysed validation protocols for compliance with FDA Quality System, MDD and ISO 13485 guidelines.

PROJECTS:

Medical Device Regulatory Strategy for a Class II Device, San Jose State University

Developed User Needs, Design Inputs, Outputs, Design & Development Plan, and Design Review Record for a class II device.

Developed Risk Management Plan, hazard traceability matrix and risk control measures adhering to ISO 14971 requirement.

Lead document control processes by creating SOP’s, Project plans, Status Reports and Purchase Requirements.

Developed a Sterilization, Packaging and Biocompatibility Plan adhering to the ISO 10993 standards.

Mechanical Heart Valves – Masters Project, San Jose State University

Determined the ideal pressure and flow rate by varying the control parameters in the Mock circulation loop (MCL.)

Mapped the physiological resistance, compliance, and impedance in the MCL and achieved a 92% accuracy.

Received the Davidson Student Scholarship award in the College of Engineering for best Master’s Project.

Prototype of a Non-Invasive Glucometer, Organization De Scalene

Collected samples and correlated the blood glucose and salivary glucose levels using principle of Spectroscopy.

Analysed the data obtained from the spectrometer and performed statistical measures such as t-statistic, ANOVA, and Gage R&R using software’s such as Minitab and GraphPad PRISM and obtained an Accuracy of 97.3%.

Authored SOP’s related to the design, development, operating, manufacturing and packaging of the device.

Maintained Spreadsheets, Managed Databases and updated the supervisor with the current status of the project.

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