Vishwateja Guntupally
St.Paul
Summary
Experienced Quality Engineer with a demonstrated history of providing solutions to complaints, CAPAs, risk management activities, and support during audits. Strong QMS professional is skilled in root cause analysis, product sterilization, and data analysis. I am always interested in the next challenge, with new technology that will help save a patient's life.
Overview
7
7
years of professional experience
Work History
NPI Quality Engineer
Molex
06.2022 - Current
- As the NPI Quality lead, the project pipeline was developed to reduce 14% of quality issues for new products through release analysis and assistance based on pFMEA analysis.
- Experience in leading all stages of project management, including project scope, identifying project deliverables, stakeholder communication, creating project timelines, weekly project tracking, technical presentations, project commitment, managing issue logs, tracking quality deliverables, and other essential project management tools.
- Oversaw the development and validation of pertinent test methods for product design and manufacturing, ensuring meticulous adherence to quality parameters.
- Mentored and coached two engineering co-ops, providing deep insights into quality processes, and guiding them to achieve project goals and metrics.
- Evaluated their performance to make the best hiring decision.
- Leveraged JMP for statistical analysis and design of experiments (DOE), optimizing test methods, and quality processes to ensure product reliability and compliance.
- Reduced average non-conformances in First Article Inspections (FAI) by 23% by guiding suppliers in the application of lean manufacturing and quality control (QC) principles, as well as addressing challenges resulting from changes in production methods.
- Investigate inspection methods to confirm they are suitable for the application and write Gage Use Instructions to ensure Test Method Validations and GR&Rs are in place where necessary
Quality Engineer
Phillips Medisize
01.2020 - 06.2022
- Mastered in authoring quality technical documents, including but not limited to software validation, Master Validation Plan (process), Failure Mode Effect Analysis - PFMEA/DFMEA, manufacturing procedures - packaging/inspection, incoming inspection, technical documents, sterile adoption reports, bill of material updates, design history files, and test method validations.
- Analyzed working with the validation and project team to update the risk management plan and master validation plan for the scope of the project.
- Responsible for cross-functionally coordinating project tasks, project risks, milestones, and objectives with each Phillips site lead and extended teams to ensure the success of projects.
- Supporting NPI activities, including developing and executing URS, IQ, OQ, PQ, and PV for product transfer.
- Experienced in NPI/NPD design verification projects of Class II and III medical devices.
- Successfully led two (Class II and III) medical device development projects through Design Verification and Design Output.
- Excelled in Supplier Production Part Approval Process (SPPA/PPAP) activities, reducing overall project time by 30% through enhancements to the global supplier quality process.
- Monitor daily manufacturing and performance data for product quality issues, and assign engineering teams to resolve issues through design changes, test method updates, or product specification updates.
Process Engineer
Teva Pharmaceuticals
08.2019 - 01.2020
- Evaluated equipment specifications and batch records to ensure their completeness and suitability for equipment usage
- Investigate process capability constraints of tablet forming machine, implement tooling and machine improvements, and complete full validation for the machine
- Diagnose automated mfg
- Equipment failures and collect data to identify root causes and develop sustainable solutions using the DMAIC process
- Executed detailed A3 (Fishbone, 5 WHY, 6S, Fault Tree, C&E Matrix, DOEs) to improve OEE of bottleneck process by 10% allowing business to reduce backlog
- Identified and eliminated bottlenecks in the production line, resulting in a 20% increase in throughput
Manufacturing Engineer
Thermofisher Scientific
06.2018 - 06.2019
- Designed experiments and applied statistical analysis such as ANOVA, Gage R&R, percent tolerance, and attribute agreement to validate test methods
- Created, maintained, and performed audits on quality documents
- Authored URS (User requirement specification) and conducted acceptance tests for Test fixture development
- Streamlined reduced downtime in a manufacturing unit by 25% through efficient implementation of product design changes and improved manufacturing efficiency by 20% thereby achieving cost savings of $100,000 per year
- Co-ordinated with logistics and equipment teams to determine and introduce optimum plant layout, equipment, tooling, and racking in Final Assembly to achieve maximum efficiency
- Led Process efficient assembly station layout to reduce operator material movement by 20%
Education
MS - Mechanical Engineering
Texas A&M University
BS - Mechanical Engineering
JNTU
Skills
- ISO 13485
- ISO 14971
- IEC 60601
- IEC 62304
- JMP (SPC, DOE)
- SolidWorks
- SAP
- Project management
- Python
- Tableau
Timeline
NPI Quality Engineer
Molex
06.2022 - Current
Quality Engineer
Phillips Medisize
01.2020 - 06.2022
Process Engineer
Teva Pharmaceuticals
08.2019 - 01.2020
Manufacturing Engineer
Thermofisher Scientific
06.2018 - 06.2019
BS - Mechanical Engineering
JNTU
MS - Mechanical Engineering
Texas A&M University
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