Gwendolyn Bodry

**** ********** ***** **********, ** 33763 USA 1-321-***-**** acxdle@r.postjobfree.com

QUALITY ENGINEER PROFILE

Accomplished, Outcome Driven, AS9100 ISO 13485:2016, and ISO 9001:2008 Lead Auditor, CMMI, and Lean and Six Sigma Greenbelt Certified Quality Engineer with over 16 years’ experience Initiated and Supported Lean Initiatives with successful results Created, Revised and Maintained all aspects of Internal Audit program including external ISO Registrar Audits Implemented, Controlled, and Ensured Effectiveness of Corrective and Preventive Action System Created Technical Documentation based on Inputs from Quality, Test, Manufacturing, Customer, and MIL Standard Requirements Fully Computer Literate, including Windows OS, Microsoft Word, Excel, Power Point, Project, and Visio as well as SharePoint, Agile PLM, Made 2 Manage and Cost Point ERP Systems Knowledge of ITAR and EAR Requirements for Export Compliance Control Earned Multiple Awards for Exemplary Performance US Citizen available for Travel and Relocation.

CORE COMPETENCIES

Team Building

ISO 13485:2016

Root Cause Analysis

Auditing

Process Analysis

Process Improvement

Six Sigma Methodologies

Lean Methodologies

ISO 9001:2008

Documentation

AS9100 Revision C

21 CFR 820

Self Motivated

Communication

Decision Making

CMMI Requirements

Corrective and Preventive Action

Cost Reduction

Project Management

Computer Literate

BAUSCH AND LOMB – Clearwater, FL 03/2015 - PRESENT

QUALITY ENGINEER

KEY CONTRIBUTIONS AND ACHIEVEMENTS:

Team member of a corporate initiative to incorporate a recent acquisition into the Clearwater facility. Review and provide oversight for the Quality Management System to ensure processes meet ISO 13485:2003 and 21 CFR 820 requirements.

Oversee quality aspects of Class II and Class III medical devices.

Conduct internal audits to verify conformance to ISO 13485:2003, Medical Device Directive and 21 CFR 820 requirements.

Initiate, manage, and close Non-conformances and Corrective / Preventive Actions with in-depth Root Cause Analysis.

Create validation protocols / strategies as required. Participate with Engineering and Manufacturing in the development and review of IQ/OQ/PQ/PV protocols and reports for product and/or process enhancements.

TANDEL SYSTEMS – Oldsmar, FL 11/2014 – 03/2015

QUALITY ASSURANCE MANAGER

KEY CONTRIBUTIONS AND ACHIEVEMENTS:

Recruited, hired, supervised, and motivated staff in the Configuration Management and Quality Departments.

Maintained expenses below budget through accurate planning, waste reduction, purchasing, and cost effective operating procedures.

Investigated and resolved customer issues, ensuring customer satisfaction and repeat business.

Assist Engineering, Procurement, Program Management, and Executive Staff in understanding and reorganizing departments for lean processes and AS9100 conformance.

Review Customer Quality Clauses during Purchase Order / Contract Review to determine organizations ability to meet requirements. Plan and flow down requirements to all effected departments.

SPARTON BROOKSVILLE, LLC. – Brooksville, FL 04/2014 – 08/2014

QMS QUALITY ENGINEER

KEY CONTRIBUTIONS & ACHIEVEMENTS:

Created and Instituted a Layered Process Audit Program. Trained and manage a team of 15 auditors to AS9100 Rev C requirements and ISO 19011 Auditing Guidelines.

Manage the Quality Management System, review metrics and determine level of process effectiveness and areas for improvement. Assist Departmental Management for QMS conformance and improvement implementation

Management Representative for 3rd Party Registrar and Customers related to AS9100 and ISO 9001:2008 topics.

Gwendolyn Bodry – PAGE 2

1-321-***-**** acxdle@r.postjobfree.com

L3 COMMUNICATIONS – LINKABIT – Melbourne, FL 12/2012 – 04/2014

QUALITY ENGINEER II

KEY CONTRIBUTIONS & ACHIEVEMENTS:

Created and Instituted a Layered Process Audit Program. Trained and manage a team of 15 auditors to AS9100 Rev C requirements and ISO 19011 Auditing Guidelines.

Manage the Internal Audit, Corrective / Preventive Action and Continual Improvement programs and provide metrics to Executive Leadership.

Liaise between 3rd Party Registrar and Customers for Organizational Quality Management related topics.

Consolidated two AS9100 Certifications by restructuring to a campus certification thereby saving the organization 20k per year in registrar maintenance, fees, and additional audits.

Meet quarterly with Executive Leadership to conduct Quality Management Reviews.

Assist Supplier Quality Engineers with initial Supplier Assessments by conducting 2nd Party Audits.

DRS TACTICAL SYSTEMS, INC. – Melbourne, FL 08/2003 – 12/2012

QUALITY ENGINEER

KEY CONTRIBUTIONS & ACHIEVEMENTS:

Streamlined the Corrective Action, Quality Alerts, First Articles, Problem Reports and Internal Audit processes by creating electronic systems within Agile PLM for creation, resolving, closing, and verifying effectiveness.

Manage the Internal Audit and Corrective Action programs and provide metrics to Senior Leadership.

Team member of a Mentor / Protégé program to assist a Small, Disadvantaged, Woman Owned business to become ISO 9001:2008 Certified by assisting in the creation and implementation of their Quality Management System.

Completed Blackbelt project which saved the organization over 260k per year in process streamlining and rework elimination.

Qual-Tech

Merritt Island, Florida

Certification – Aerospace Auditor Transition Training (AATT) 04/2014

Certification - AS 9100 Rev C Lead Auditor 04/2013

British Standards Institute

Reston, Virginia 08/2011 AS 9100 Auditor Training

Arizona State University

Phoenix, Arizona

Lean Six Sigma Greenbelt 10/2009

Keiser University

Fort Lauderdale, Florida

Business Administration Associate Degree Equivalent 05/2005

American Society for Quality

Milwaukee, Wisconsin

Certificate – ISO 13485:2016 – IN PROCESS 11/2016

Certification – Certified Quality Auditor cert #41362 12/2010

Certification – ISO 9001:2008 Lead Auditor 06/2008

Layton High School

Layton, Utah

Diploma – High School 05/1989

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