Quality Engineer Medical Device

Paul T. Moon

linkedin.com/in/paul-t-moon

* *******@*******.*** 716-***-****

Professional Summary

Quality Engineer with 20 years of progressive quality leadership experience developing, implementing and maintaining quality systems to reduce risks, ensure compliance and drive improvement in product quality, safety and productivity.

Industry Experience:

Medical Device, Aerospace

Functional Experience:

Supplier Quality Management, Quality Systems, Quality Engineering, Inspection Supervision

Selected Skills:

ISO 9001/ISO 13485/AS9100

Product/Process Validation

Quality Auditing

Root Cause/Corrective Action

New Product Introduction

APQP/PPAP

Metrology/Calibration

Microsoft Word, Excel, PowerPoint

Minitab

Professional Experience

Integer (Greatbatch Medical) 1980 - 2000, 2003 - 2010, 2018 - 2020

Designer/manufacturer of power supplies for implantable medical devices.

Senior Supplier Quality Engineer (2018 - 2020)

Monitored supplier quality and acted as primary quality contact to suppliers. Performed supplier audits and tracked resulting corrective action plans. Participated in qualification activities for new products and suppliers. Evaluated and qualified supplier-driven change requests.

Implemented revised Supplier Quality Management process.

Validated Supplier Risk Rating software.

Coordinated monthly Supplier Performance meetings.

Receiving Inspection Supervisor/Supplier Quality Engineer (1993 - 2000, 2009 - 2010)

Managed Receiving Inspection Department. Developed inspection methods, procedures and acceptance criteria. Trained Technicians and Inspectors. Managed quarantine and disposition of discrepant materials. Monitored supplier quality and acted as primary quality contact to suppliers. Performed supplier audits.

Reduced quarantine inventory by 90%.

Reduced Receiving Inspection time by 75%.

Designed and implemented supplier dock-to-stock system that reduced on-hand inventory.

Quality Engineer (1991 - 1993, 2003 - 2009)

Monitored and maintained Quality for various production lines. Coordinated quality activities for development and qualification of new implantable capacitor models and implantable battery modifications. Developed inspection and process control methods, procedures and acceptance criteria. Developed and performed studies and data analysis for process improvement.

Designed & implemented a stage-gate qualification system for battery termination configurations.

Participated on Kaizen team for capacitor operations reducing cycle time, WIP and scrap by 50%.

Participated on calibration system team that completely revised calibration system.

Quality Control Technician (1986 - 1991)

Reliability Technician (1983 - 1986)

Process Operator (1980 - 1983)

Paul T. Moon Page 2

Professional Experience (continued)

Baxter Healthcare 2013 - 2018

Designer/manufacturer of intravenous pumps

Senior Engineer, Supplier Quality

Monitored supplier quality and acted as primary quality contact to suppliers. Performed supplier audits and tracked resulting corrective action plans. Evaluated and dispositioned nonconforming product received from suppliers and tracked resulting corrective action plans.

Implemented new system for supplier assessment utilizing unique format and scoring system.

Maintained supplier scorecards and chaired monthly supplier performance meetings.

Bausch & Lomb

Designer/Manufacturer of contact lenses and eye care products 2011 - 2013

Senior Supplier Quality Engineer

Monitored supplier quality and acted as primary quality contact to suppliers. Performed supplier audits and tracked resulting corrective action plans. Managed supplier quality agreements. Assisted receiving inspection with gauging and inspection issues.

Participated on multiple system redesign teams including Supplier Quality Management Systems, Supplier Scorecards, and Supplier Information Management Systems.

Woodward HSC, Inc. 2000 - 2003

Designer/manufacturer of servo valves for aerospace and medical applications

Quality Assurance Engineer (2001 - 2003)

Primary contact to customers for quality issues including contract review, corrective actions, new model development and training of personnel to customer and regulatory requirements.

Implemented AS9102 First Article Inspection Reporting.

Qualified as Quality Representative for Honeywell Aircraft ES&S, and Pratt & Whitney Canada.

Participated on teams to improve quality and on-time delivery to customers.

Quality Systems Engineer (2000 - 2001)

Maintained the Quality Management System. Insured compliance to ISO 9000, AS9000 and Federal Aviation Authority (FAA) requirements.

Reconfigured and streamlined the Contract Review system.

Education

State University of New York at Buffalo

Bachelor of Science - Business Administration

Associate in Applied Science - Technology

Training/Certification

ASQ Certified Quality Auditor

ASQ Certified Quality Engineer

Supervisory Studies/Leadership - Cornell University

Six Sigma - Woodward/Greatbatch

Lean Manufacturing - Woodward/Baxter

Geometric Dimensioning & Tolerancing

Certified IPC Specialist IPC-A-610 Acceptability of Electronic Assemblies

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