Quality Engineer Design

**** ***** ******, *****#***, King of Prussia, PA 19406

www.pindisolutions.com

Contact – Priya

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

Pindi Recruiting Manager

(240) 706 - 2178

Shamanth Ramesh – Quality Engineer

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PROFESSIONAL SUMMARY

Extensive knowledge on new product documentation including product requirements, test protocols and reports, and risk analyses to develop a complete DHF and DMR files by employing ISO 13485 standards and FDA Quality System Regulations.

Well versed with improving statistical methodologies used on Test Method Validation, preparing test plans and developing protocols.

Experienced in CAPA documentation, investigation, root cause analysis and closing NCRs.

Extensive experience in ISO 14971 Risk Management: hazard analysis, fault tree, FMEA, FMECA and the strong relationship between risk and V&V activities.

Successfully developed, maintained and updated Standard Operating Procedures (SOPs), Design History Files

(DHF) and Design of Experiments (DOE).

Developed Fish Bone analysis, Fault Tree analysis, 5-Why and Why-Why analysis.

Good experience in grading suppliers, developing supplier matrix and preparing Supplier Corrective Action Reports (SCAR).

Strong knowledge of QSR Part 820, ISO 13485, ISO 14971.

Proficient with current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).

Led cross functional team on the Manufacturing Process Failure Modes and Effects Analysis (PFMEA).

Applications: Microsoft Office, Matlab, SolidWorks, CATIA, AutoCAD, Pro-E, SolidEdge, Ansys, MSC Patran

& Nastran, CNC G-code Programming, Minitab

PROJECT EXPERIENCE

Boston Scientific Spencer, IN

Quality Engineer Jul’13 - Present

Created process FMEAs to support validation and analysis and design transfer project.

Defined validation approach, developed protocols (IQ/OQ/PQ, PV) and assisted in validation executions as required. Wrote Validation Summary Reports.

Created and executed test protocols.

Represented quality assurance in new product development team, reviewed drawings and specification, developed reliability test plan, assisted vendors in developing manufacturing/test methods of components/assemblies and developed FMEA.

Performed Test Methods validation activities as required and delivered Gage R&R studies for inspection tool.

Conducted a variety of testing on medical devices: dry run and functional testing.

Trained associate on Test Method Validation procedure, protocols and interpretation of Gage R&R statistical analysis.

Performed gap analysis of current standard operating procedures (SOPs) against industry and regulatory standards to identify missing SOPs and quality control documentation

Created several Change Orders through Agile and documented the quality system record.

Validated the Test Fixtures, Test Assemblies and Gauges.

Developed and completed PFMEA(s), Risk Management Plans, and/or Risk Management Reports.

Implemented and managed Design History File (DHF), Functional design requirements, design input and output

(I/O), design Verification and Validation (V&V), and design risk management analysis. Shamanth Ramesh

Quality Engineer

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Maintained all design changes documents through management quality control (ECN, DCO, DHF) for auditing and to be in compliance with FDA regulations.

Performed Gap assessments and closed the gaps as part of DHF remediation.

Gathered source documents for DHF and created Design Trace Matrix (DTM). Authored protocols and reports where necessary to complete the DHF.

Led and drove product/process design responsibilities in a highly-regulated medical environment, including statistical validation according to FDA requirements.

Ensured design for manufacturing elements are incorporated into new product development activities.

Implemented and maintained plant wide calibration system and drawing control/document control system.

Applied knowledge of GD&T and tolerance stacking to ensure high precision gages meet design criteria.

Provided statistical process control (SPC), process capability studies and statistical analysis support to manufacturing and engineering departments.

Evaluated and completed non-conformance reports, product complaints, CAPA’s and field actions.

Identified and created trend analysis for key quality performance indicators and NC/CAPA effectiveness monitoring.

Conducted problem solving and root cause analysis to support failure investigations initiated to resolve quality problems identified from customer complaints, internal non-conformances and manufacturing process yields.

Reviewed new and revised inspection criteria for proper sampling plan, understanding of inspection technique, availability of inspection tools and accuracy of the acceptance criteria.

Managed supplier validation activities including supplier assessment, protocol development, and generation of supplier validation master plan(s).

Performed supplier evaluations for updates to the Approved Supplier List (ASL).

Facilitated the Supplier Change Notification/Change Request (CR) Process for changes to component specifications and supplier manufacturing processes.

Reviewed and approved supplier process validation documentation for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing operations facility moves. C.R Bard Inc. Salt Lake City, UT

Quality Engineer May’11-Jun’13

Developed Validation Master Plan (IQ/OQ/PQ/VMP) validations to qualify automated equipment and processes in an FDA-regulated and ISO 13485 compliant environment.

Performed independent reviews to protocols and reports associated in Test Method Validation studies,

Addressed deficiencies and issues in TMV Protocols and Reports, in order for TMV documents to meet quality requirements.

Created Standard Operating Procedures (SOP), and optimized engineering procedures.

Managed comprehensive tracking sheet for NCMRs remediation activities and the Master validation plan which includes equipment and tools serial numbers, protocols execution progress and verified calibrated equipment.

Developed PFMEA(s), Risk Management Plans, and/or Risk Management Reports.

Performed retrospective review of all design and process changes and determined impact to the validated state of the product, or to product key quality attributes and resolve identified gaps.

Created/managed the Protocol/procedures/checked out specifications for product testing, sourcing, obsolescence, alternates and conducted situational analysis.

Reviewed BOM and mechanical drawings. Initiated ECR, Deviation and reviewed materials in the MRB area.

Set up new engineering drawing system, planned out, specified equipment for and wrote assembly & testing procedures for manufacturing plant.

Applied LEAN, 5S and TQC (Total Quality Control) to identify/reduce waste additions in production lines, such as motion, process, wait, over-produce, transportation, inventory and rework.

Performed qualification (IQ, OQ, PQ, validation) for production release. Shamanth Ramesh

Quality Engineer

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Followed models through prototype builds, FEA, reliability testing and production tooling release.

Updated as required Device History Records (DHR) to ensure that they are fully aligned with the procedures in force as well as the DHF(s).

Performed complex tolerance analysis through six sigma methodology in order to minimize the design iterations and meet aggressive design deadlines.

Planned Design Change plan and developed strategies for Technical Reviews to facilitate Design Transfers.

Supported and trained the team for Design Transfers to manufacturing.

Authored and Managed Validation Matrices, Technical Reviews, PFMEA and Risk Files.

As required updated Design History Files, Risk Management Files and DFMEA.

Reviewed and approved GMP document including procedure revisions, change requests, protocols, and reports.

Administered/managed the CAPA system to ensure completeness of documentation including root cause analysis, corrections and corrective actions as well as provide CAPA metrics.

Analyzed data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis. Coordinated implementation of corrective actions and preventive measures.

Coordinated, facilitated, and supported Root Cause Analysis, investigation writing, and CAPA training programs.

Tracked/reported status of investigations and escalated concerns to management on a timely basis.

Audited suppliers for conformance and tracked supplier’s corrective actions to audit findings to closure.

Presented supplier change control plans to the Change Control Board for approval prior to implementation of a supplier change notification request.

Supported Internal/External Audits as needed.

Reviewed, assessed and evaluated validation protocols (IQ, OQ, PQ) for compliance to procedures and regulations, statistical validity and approval.

EDUCATION

MS in Aerospace Engineering, University of Michigan. B.E in Mechanical Engineering

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