VAMSHI S

ac1nwf@r.postjobfree.com

475-***-****

Experienced Quality Engineer professional with 2 years of experience in Medical Device and Automobile arena specializing in Manufacturing, Quality, Process design and Product Development.

TECHNICAL SKILLS

Lean Six Sigma and Kaizen, QSR 21 CFR Part 820, ISO 13485, Executing Validation Protocols (IQ, OQ, PQ), APQP and PPAP.

SolidWorks, AutoCAD, FEA, GD&T, Blueprint Reading, BOM’s, Microsoft suite (Word, Excel, PowerPoint), Visio, Minitab.

WORK EXPERIENCE

QUALITY ENGINEER

ACRA-CUT, MA. JUNE 2016 - JUNE 2017

Developed and Implemented processes and manufacturing practices to the ensure quality compliance to FDA and EU Regulations.

Increased manufacturing efficiency by continuously monitoring and improving initiatives by utilizing Lean, Kaizen and Six Sigma.

Participated in the reliability assurance of all design activities, design controls and reviews.

Worked cross-functional in executing Test Method Validation, Validation Master Planning, (VMP), quality planning, process controls, product assurance plans.

Improved and implemented the quality programs and systems to applicable standards in aspects of performance, safety, maintenance and appearance.

Created, Revised, Developed and Documented the PPAP and APQP documents and ensured deliverable evidence accordingly.

Performed machine, process capability and performance studies to recommend changes and/or upgrades.

Lead Material Review Board (MRB) meetings and involved in Change Orders.

Visually analyzed the data by using Statistical techniques to aid in the development of validation protocols, testing, design, and process improvements.

Reduced non-conformances by performing root cause failure analysis (RCA), FMEA and implanting CAPA activities. Developed documentation related to the Design &Process Failure mode effective analysis.

ASSOCIATE QUALITY ENGINEER

ANANTH TECHNOLOGIES JUNE 2014 - AUG 2015

Determined quality requirements in products based on technical customer/supplier and company requirements.

Established, maintained and implemented the quality programs and systems in compliance with Quality Management System thus by ensured production quality.

Performed User assessments and Risk assessments and updated the process requirements.

Determined the root cause of Non-Conformances, drove Corrective and Preventive actions (CAPAs) accordingly.

Performed system Audits, reviewed device history records (DHR) and closed the non-conformances.

Worked on reducing waste production and ensured efficiency by implementing Lean Six Sigma tool.

Worked as CAPA owner and drove CAPAs on product, process and supplier issues from initiation to closure (Investigation-Action-Effectiveness).

Worked on writing the Quality Manual SOP's. Created and revised Quality Assurance related to SOP’s.

Worked closely with other departments to determine equipment specifics (automation, output, quality etc.) to ensure a safe, high quality and efficient production environment.

Recorded evaluated and documented results and compared to expected results.

EDUCATION

University of Bridgeport Bridgeport, CT.

Master of Science in Mechanical Engineering Sep 2015 – May 2017.

Nalla Malla Reddy Technological university Hyderabad, India.

Bachelor of Technology in Mechanical Engineering Aug 2011 – March 2015

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