VISHNUPRAVEEN PASUMPON

682-***-**** adctod@r.postjobfree.com https://www.linkedin.com/in/vishnupraveen-pasumpon-b79379164/

Qualified and skilled Quality Engineer Professional in FDA regulated environment with handful of experience in the Medical Device industry; experienced with Testing and Design Verification & Validation Engineer and applied understanding of ISO 13485 and 21 CFR Part 820 - Quality System Regulation (QSR).

Expertise in Test Method Validation (TMV), Process Validation, Change Control, Product development and product maintenance such as Quality Plans, Verification and Validation Testing activities, PFMEA’s, FMEA's, Customer Complaints.

Expertise in statistical analysis to provide objective evidence at Investigation and Root Cause phases of CAPA projects including NCMR, FMEA, Customer Complaints, Document control and Product Quality Improvement.

Experience in process capabilities, DOE, PFMEA, DFMEA, Failure Investigations, demonstrated problem solving and GMP(Good manufacturing practices) as per 21 CFR Part 820 - Quality System Regulation (QSR).

Comprehensive knowledge of product development life cycle, Gap Analysis, Trace Matrix, Gage R&R, GD&T, DOE and Validation Protocols SOP’s such as (IQ’s, PQ’s, OQ’s).

Experiences include APQP, CAPA, Device Master Record (DMR), Design History Files (DHF), and Device History Records (DHR), change control, design control, Internal & external audits on the medical products.

Experience with Autodesk Fusion 360, problem solving techniques involving Lean/Six Sigma statistical tools such as Minitab, MATLAB.

EDUCATION

The University of Texas at Arlington, TX

Master of Science in Industrial Engineering Jan 2016 - Aug 2018

Anna university, India

Bachelor of Science in Mechanical Engineering Jun2010 - May 2014

WORK EXPERIENCE:

Quality Engineer, MENTOR(Johnson & Johnson) Irving, TX (SEP 2019- Current)

Assisting in lead project teams and provide major input in the development and manufacture of new products as well the maintenance of current products, materials and processes.

Functioning as a quality representative on multi-functional product development teams in matters relating to Quality Engineering.

Supporting design control and process validation activities for new and change product efforts.

Monitored facility and implemented Quality systems for products in accordance to cGMP and ISO standards.

Involved in Test method validation to ensure effective and efficient use of Quality Engineering techniques such as risk analysis, test method development, statistical data analysis, and the development of sampling plans.

Assisted in thorough investigation of quality issues and oversee implementation of effective corrective and/or preventive action.

Deep knowledge of FDA Medical Device Reporting and international medical device regulations.

Accountable to ensure compliance with the Quality system Regulation regarding quality and manufacturing process related complaints and involved in root cause analysis to deliver evaluation summary for customer complaints for the site.

Supported in Lead project such as Manufacturing Process Information ( MPI) documentation related with Manufacturing, design, Quality and Quality Improvements for the various device manufactured in site.

Supported in Skip lot Project to estimate and optimize the incoming supplier products inspection and test methods timespans.

Sustaining Quality Engineer, NP Medicals- Clinton, MA (Apr 2019- June 2019)

Worked as a Quality Engineer on Product Development, Process Improvement, streamlining and debottlenecking of manufacturing processes of PAV/LAV Valves, in adherence to GxPs, ISO Guidelines, FDA UDI regulations.

Developed Verification/Qualification deliverables including Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), and Summary Reports in accordance with FDA regulations, particularly 21 CFR Part 11 and GMP for PAV/LAV valves in specific.

Assisted in evaluating SCAR and FAI.

Expertise in performing facility/process validation activities SOP’s, including IQ, OQ, PQ, capability analysis, PPAP and Design of Experiments (DOE) for automated Testing equipment.

Performed Root cause failure analysis and reported with GDP (Good documentation Practices).

Performed Test Method Validation (TMV) for Visual Inspection dimensional measurement. Created test methods, fixtures for destructive strength test. Applied Gauge R&R techniques.

Coordinated with supplier quality, manufacturing engineers, material team to resolve Issues.

Quality Engineer, AZTech Technologies LLC- Wilmington, DE (Nov 2018- Apr 2019)

Collaborated with cross functional teams to facilitate Risk Management activities such as Design FMEA, Process FMEA and Risk Analysis.

Participated in implementation of quality principles at the design and initial manufacturing stage of product development.

Reviewed assembly drawings for Dimensions and tolerances (GD&T) and involved in designing the manufacturing process.

Involved in creating Deliverables like Summary Reports (VSR), Risk Assessment, Commissioning Plan, Change Control, Final Reports and Traceability Matric (RTM)..

Performed Statistical Analysis of all IQ/OQ/PQ/TMV/Monthly Metrics/Capability Analysis/ risk assessments results and created reports using Minitab.

Involved in Supplier Audits, Supplier Corrective Action Request process (SCAR) for quality and compliance.

Followed all established ISO 13485 quality procedures and participated in continuous improvement efforts.

Graduate Research assistant (Jan 2017-Nov 2018)

Enhanced honeycomb nanostructure of 3D printed Bulletproof vest with composition of CNT, Graphene, and Kevlar (Metal 3D printing).

Assisted in Optimizing nanostructure locally with different areas as required by means of using Novel 3D printing.

Performed testing of different crystal arrangements of CNT both Honeycomb and Sandwich models.

Assisted in Fabrication of metal 3D printing, 3D porous polymer printing with micro porous structure.

Conducted Research in Defense heavy vehicles honeycomb structed Tires in elevate the porosity measurements for the Graphene, fiber glass and Kevlar.

Assisted in Optimizing characteristics of Expanded polypropylene such as shock absorption, Thermal insulation, heat resistance, weather resistance, oil resistance and chemical resistance to meet the desired standard.

Manufacturing Engineer, Poly Seals Pvt. Ltd, India (March 2015- Dec 2015)

Co-ordinated in Creating manufacturing strategies for new projects, prepared product and process reports, work instructions.

Assisted in providing manufacturing decision-making instructions by calculating production, labor and material costs, reviewing production schedules, estimating future requirements

Applied Process Failure Mode Effects Analysis (PFMEA), Statistical Process Control (SPC) and Root Cause Analysis methodologies to reduce variability and improve quality

Supporting the continuous Quality improvement by Planned and implemented the 5S lean manufacturing procedures and designed method to organize a workspace for efficiency and effectiveness.

Quality Engineer, SAS Industries, India (May 2014 – Feb2015)

Assisted in developing a new procedure with DFMEA tool on valve bodies products for quality improvement by Metallographic image analyzer especially on the fillet welds as required to reduce variability and improve quality.

Updated work instructions and created inspection criteria to verify exact composition of metal and metals alloys especially Ni-hard and grey iron castings with help of ARL 3460 spectrometer for quality improvement.

Utilized manufacturing quality tools such as FMEA, DFMEA, PFMEA, SAP, control plans, process verification/validation plans.

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