Engineer Quality

Bharath S Turuvekere, ASQ CQE

**** ****** *****

Elkridge, MD 21075

Phone: 757-***-****

Email:

*******.**********@*****.***

Objective: Provide Quality Engineering

expertise, Develop processes for better productivity,

Engage in Research and Development with usability as key

focus, and Steer team to success through leadership, time

and cost management.

Professional Experience:

Musculoskeletal Clinical Regulatory Advisers, LLC

Duration: June 2nd, 2014-Current

Designation: Manager, Quality Engineering

. Assist clients in building and maintaining all

aspects of a sound quality management system for

medical devices and pharmaceuticals that is

compliant with respective regulations, directives

and standards.

. Audit client's quality management system for

compliance to 21 CFR 820, 21 CFR 210/211, ISO

13485:2003, ISO 9001 and other relevant regulations,

directives and standards.

. Assist clients in their Pre-Approval and Post-

Approval Inspections.

. Assist clients in creating and reviewing Device

Master Records, Device History Records and Batch

Records.

. Assist clients with creation and review of technical

files/Dossiers.

. Assist clients in creating and review of Risk

management process (QRM) as per ICH and ISO

standards.

. Assist clients in creation and review of essential

requirements checklist.

. Assist clients with 21 CFR 803, 21 CFR 806 and

vigilant reporting (VR).

. Assist clients in improving their QMS process (e.g.

CAPA process, nonconforming process, etc.)

. Assist clients in resolving FDA 483 observations and

notified body ISO 13485:2003 audit observations.

. Assist clients in evaluating supplier management

programs.

. Assist clients in performing verification and

validation activities from plan through completion.

. Assist clients in achieving lean manufacturing

goals.

GE Healthcare, Laurel, MD, USA

Duration: August 15th 2011-May 15th, 2014

Designation: Lead Quality Assurance Engineer

. Responsible for ensuring quality and regulatory

compliance in accordance with documented procedures

for all aspects of functional responsibility.

. Audit for compliance to 21 CFR 820, ISO 13485,

93/42/EEC, SOR/98-282 and ISO 62304 (SDLC).

. Responsible for the development, implementation, and

continuous improvement of process effectiveness and

efficiency at the site.

. Ensure process efficiency and compliance

effectiveness through the review and approval of

process verification and validation plans, including

Master Validation Plans (Site Level), Validation

Master Plans (Product or Process specific plans)

through development and implementation.

. Support continuous product and process improvement

through detailed failure analysis for non-

conformances, and investigates, develops and

implements effective and compliant solutions for

product or process corrections, retrospective and

remediation action plans, and for corrective and

preventive actions (CAPA Program).

. Review and approve risk assessments, including but

not limited to PFMEA, DFMEA, Fault Tree Analysis,

Failure Mode Analysis, etc. Supports design

mitigation efforts.

. Ensure process compliance through the development,

review and approval of simple yet comprehensive

procedures, work instructions, flowcharts, forms,

templates, checklists, worksheets, and other product

and process related documentation.

. Perform a broad variety of tasks in support of

product and process design as assigned by the

departmental manager.

Stryker Communications, Flower Mound, TX, USA

Duration: December 8th 2008- July 15th 2011

Designation: Quality Engineer

. Audit for compliance to 21 CFR 820, ISO 13485,

93/42/EEC, SOR/98-282 and ISO 62304 (SDLC).

. Performed Root cause analysis for field failures and

customer complaints.

. Performed trending of Complaints and Non-conforming

products and acted as Liaison between R&D, Customer

Service and Customer

. Set up Quality Management System auditable to FDA

21CFR820 and for ISO 13485 at OEM.

. Monitored process quality parameters of Off-shore

OEM manufacturer

. Wrote Technical Assessment for Medical Device

Reporting, Product Field actions and Management

Reviews.

. Division project lead for Agile Product Lifecycle

Management system.

. Conducted Corrective and Preventive Action (CAPA)

for products and processes.

. Developed, Reviewed, Updated, and Approved

Procedures to be used for Product line and Business

processes.

. In-house expert on Failure Mode and Effects Analysis

(FMEA), Fault Tree Analysis and Functional Analysis

as a part of Risk Management.

Hughes Network Systems, Gaithersburg, MD, USA

Duration: July 23rd 2007- November 15th 2008

Designation: Manufacturing Engineer/ Process Engineering

. Provided process support for complete SMT Line from

off-line feeder programming, Solder Printing, Chip

Shooters, Oven and AOI

. Train Junior Engineers on SMT processes.

. Conducted internal audits as per ISO 9001

requirements.

. Provide guidance on quality deliverables for

Telematics project for Mercedes Benz and Chrysler.

. Validate and Monitor Process Quality parameters of

Contract Manufacturer (Offshore).

. Audited Suppliers per Hughes Network Systems and

ISO/TS 16949 standards.

. Performed root cause analysis for Design phase, Pre-

Pilot and Pilot phases.

. Designed Testing process for telematics modules.

. Created programs for BGA rework on Air-Vac machine.

ARAI Americas, Inc. Norfolk, Virginia, USA

Duration: June 1st 2006- July 8th 2007

Designation: QA Specialist

. Applied Transition from ISO 9001 to ISO/TS 16949.

. Performed Production Part Approval Process (PPAP),

Advanced Product Quality Planning (APQP),

Statistical Analysis Studies, Process improvements.

. Prepared Product Quality Control Tables

(PQCT)/Control Tables for Honda and Toyota products.

. Prepared Process Failure Mode and Effects Analysis

(PFMEA) for all product lines.

. Conducted 8D, Fishbone analysis, 4W/1H, Fault Tree

Analysis (FTA) for root cause analysis on failures.

. Conducted In-house and Supplier Audits to enforce

adherence to Toyota, Honda and ISO/TS 16949

requirements.

. Improved Warranty Return Rates through corrective

and preventive measures by implementing process

improvements.

. Audited Suppliers per ISO/TS 16949 and ISO 9001

standards.

Old Dominion University

Duration: August 2005- May 2006

Designation: Research Assistant

. Worked on Life cycle assessment and costing as a

Research Assistant.

. Researched on environmental impact assessment of

different processes.

. Studied effect of Plastics and Injection molding

process on environment.

. Developed procedures for building LCA models on

SimaPro and analyzing the results through Regression

analysis.

. Tested software's such as SimaPro, EIOLCA, Excel and

TCAce extensively

Software Packages

. HP Quick Test Professional (QTP)

. Mercury Quality Center (QC)

. Mercury WinRunner

. Loadrunner

. Solid Works

. Minitab

Certifications

. Certified Quality Engineer (CQE) from ASQ

. ISO 13485:2003 Lead auditor

. ISO/TS16949: 2002 Internal Auditor

. Universal Platform P Programming

. Chrysler Development System, Process Sign Off,

Layered Product Audit.

Skills

. Failure Mode and Effects Analysis (FMEA).

. Fault Tree Analysis (FTA) and Functional

Analysis (FA).

. Process Quality Control Table (PQCT)/ Control

Table.

. Lean Manufacturing and Six Sigma Concepts.

. Audits- Internal Audits and Supplier Audits.

. Project Management.

. Software Automation Tools.

. Kepner-Tregoe Problem Solving technique

Education: Master of Science (Mechanical Engineering) from Old

Dominion University, Norfolk, VA

Bachelor of Engineering (Mechanical Engineering) (Dayananda

Sagar College of Engineering, India)

Contact this candidate