Benjamin E. Mattox

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

Naples, Florida 34108

acfxsa@r.postjobfree.com

239-***-****

SUMMARY

• Quality Systems Professional (M.B.A.) with expertise in the implementation and maintenance of ISO13485:2012, 21 CFR Part 820,

Medical Device Regulation (SOR98-282), Medical Device Directive (93/42/EEC), and MHLW Ministerial Ordinance compliant

quality systems. Additional strengths include Process Based Internal Auditing, Supplier Auditing and Qualification, Six Sigma and

Lean Manufacturing Principals, Quality System Software Implementation, and Technical Training. Acknowledged by senior

management as possessing a unique ability to assess and connect with constantly changing Customer, Supplier and Internal Quality

requirements. Very proficient in the use of Enterprise Quality and Compliance Management System Software, Crystal Reports,

Enterprise Resource Planning (ERP) Systems, Adobe Professional, and Microsoft’s Word, Excel, PowerPoint, and Visio software

applications. Additional strengths include:

• •

Customer & Quality Focus Coaching, Mentoring and Leadership by Example

• •

Multiple Project Management Empathy & Listening Skills

• •

Solid Blend of People & Technical Skills Team Building

• •

Interpretation of Regulatory Quality Standards Facilitating Inter-departmental Cooperation

• •

Effective Communication Skills Advanced Computer Literacy

EDUCATION

Six Sigma Black Belt Certificate, St. Petersburg College, St. Petersburg, Florida, GPA 4.0/4.0

Lean/Six Sigma Certificate, St. Petersburg College, St. Petersburg, Florida, GPA 4.0/4.0

M.B.A., International Business, University of Miami, Tampa, Florida, GPA 3.25/4.0

Bachelor of Arts, Individual Studies/Management, Columbia College, Jacksonville, Florida, GPA 3.5/4.0

PROFESSIONAL EXPERIENCE & ACHIEVEMENTS

ARTHREX, INC., Naples, Florida October 2008 to Present

Quality Systems Auditor – Perform Internal and Supplier Quality System audits to ensure compliance with internal, ISO13485:2012,

FDA, MDR, MDD, and MHLW standards and regulations for a leading medical device manufacturer.

• Provide timely written reports of quality/regulatory compliance status

• Determine and document Event Risk Assessments associated with audit findings

• Review & approve corrective action plans and track corrective action plan milestones

• Develop and revise supplier qualification work instructions

• Execute the preparation, distribution, tracking and filing of questionnaires to evaluate supplier quality systems for compliance

• Ensure communication of company expectations and requirements to Suppliers

• Track Supplier certifications, and maintain and update Approved Supplier List (ASL)

EATON AEROSPACE, Sarasota, Florida (Contract) June 2006 to February 2008

Supplier Quality Assurance Engineer – Ensure effective implementation of quality assurance processes throughout the supply chain

through the identification of quality issues, containment of nonconforming material, root cause analysis, and corrective and preventive

action implementation for an ISO9001/AS9100 registered manufacturer of circuit breakers, switches and contactors/relays for use by

military and commercial aerospace industries. Develop tools needed to measure Supplier performance and work with Suppliers to

resolve quality and delivery issues.

• Evaluate Supplier OTD and DPPM data and provide appropriate feedback using monthly/quarterly/yearly scorecards

• Conduct on-site Supplier quality system audits supporting the Supplier quality assurance process

• Advise in the selection of new Suppliers and the exiting of under achieving Suppliers

• Track Supplier certifications, and maintain and update Approved Supplier List (ASL)

• Evaluate and approve or reject Supplier corrective action responses stemming from product nonconformance’s

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• Chair Supplier and Internal Material Review Board (MRB)

• Provide technical quality guidance in developing and implementing quality systems, procedures and plans

• Internal Auditor and Audit Program Coordinator

• Quality system procedure author and document control coordinator

• System administrator for the plants Supplier and internal quality management software systems

• Compile and develop training material, and conduct training sessions on plant’s quality management system software

• Develop strategies and programs that improve productivity and efficiency of work processes

• Project Lead for First Article Inspection (FAI) lean initiative

• Receiving inspection lean implementation team member

• Incoming Inspection Supervisor

BAXTER HEALTHCARE, Largo, Florida (Contract) January 2006 to June 2006

Product Surveillance Specialist II – Responsible team member for complaint investigations, which included the management,

documentation, and coordination of low to high risk complaint investigations per internal SOP’s and requirements of 21 CFR Part 803

and 21 CFR Part 820.

THE ENSER CORPORATION, Pinellas Park, Florida February 2005 to January 2006

Senior Quality Assurance Engineer – Provide process/quality engineering support to an ISO9001/AS9100 registered manufacturer of

thermal batteries, ensuring delivery of highest quality product to customers, and reducing and controlling manufacturing process defects

(i.e., scrap, nonconforming material, customer complaints). Lead efforts to identify primary root cause of defects and implement

corrective and preventive actions.

• Monitoring and measuring device (Calibration) program coordinator

• Implemented and managed an Electrostatic Discharge (ESD) program

• Nonconforming material reporting and review system coordinator

• Corrective & Preventive Action (CAPA) program coordinator

• Internal Auditor and internal audit program coordinator

• Document author, reviewer and approver, and document control system coordinator

• System administrator for the company wide electronic quality management system

MPC PRODUCTS CORPORATION, Skokie, Illinois October 2002 to October 2004

Quality Assurance Engineer (CQM) – Results-oriented quality leader for an ISO9001/AS9100 registered Aerospace manufacturer of high

performance electromechanical motion control systems with experience developing, administering, and auditing an innovative Quality

Management System.

• Collect, organize, monitor, and distribute information related to quality and process improvement functions

• Generate generic or custom reports detailing monthly supplier and internal nonconformance’s, and corrective and preventive action

analysis

• Internal Quality Management System Auditor

• Investigate and respond to customer complaints regarding quality

• Boeing delegated Source Inspector

• Project Manager responsible for managing the implementation of an electronic Enterprise Quality and Compliance Management

System

• Goal Related Improvement Program (GRIP) Project Lead, which examined and improved the process of the Corrective and

Preventive action system. Eliminated the current paper based system and its associated manual movement of paper by changing to

an electronics based system. A total reduction of 76% in queue time was achieved.

• Corporate Quality, Engineering and Manufacturing Document Evaluation Team Lead, which evaluated, verified, and validated 2200

Corporate/Departmental procedures, engineering instructions/procedures, and manufacturing instructions. Initiated and processed

over 210 Engineering Change Requests/Orders (ECR/ECO) in conjunction with project.

PILGRIM SOFTWARE, Tampa, Florida October 2000 to September 2002

QMS Software Implementation Consultant – Provided project management, process consulting, legacy system transition, technical

training, Train-the-Trainer requirements, system configuration, and follow-up implementation assistance for purchased enterprise wide

Quality & Manufacturing Integration System (Q&MIS) software. Customers included ISO9001, AS9100, QS9000/TS16949, and

ISO13485 registered manufacturing sites.

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PROFESSIONAL DEVELOPMENT

• CfPIE – Auditing and Qualifying Suppliers and Vendors – An Effective Risk Based Approach, March 2013

• Praxis Life Sciences – Computer System Validation Boot Camp, September 2012

• MBC & Affiliates, LLC – Lead Internal Auditor (21 CFR Part 820 & 11, ISO13485:2003, MDD, MHLW Ord. 2 & 169 and MDR

SOR/98-282), May 2012

• EduQuest – The CAPA Clinic, March 2011

• EduQuest – FDA Auditing of Computerized Systems and Part 11, March 2011

• Wayne Taylor – Process Validation Principles, May 2010

• Wayne Taylor – Validation Sampling Plans, May 2010

• CfPIE – Process Validation for Medical Devices, April 2010

• AQS Management Systems, Inc. – ISO9001:2008 Lead Auditor with Medical Device Focus (ISO 13485:2003), March 2010

• APLOMET – Root Cause Analysis, July 2009

• QAI – ISO13485:2003 Lead Quality Auditor, October 2008

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