Quality Engineer Manager

Eddie Reavis

Waynesville, NC *****

M: 763-***-****

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

SUMMARY

Self-motivated, versatile quality professional with accomplished background in quality systems and manufacturing. Qualified by over 30 years in manufacturing and process improvement.

Areas of Experience:

Team Optimization

Customer Service

Project Management

Risk Mgmt.

Kepner-Tregoe Problem Solving / CAPA

Auditing

Six Sigma / Statistics

Process/Software Validation

Change Management

PROFESSIONAL EXPERIENCE

THERMO FISHER SCIENTIFIC, Asheville, NC 05/2016 – 07/2019

Manufacturer of laboratory equipment [class 1 & 2 medical devices]

Senior Quality Manager

Responsible for strategically leading the site’s Quality Management System to support 21CFR820, ISO9001, ISO13485 and RoHS standards/regulations. Act as main contact during FDA inspections, customer audits and other third-party Quality System evaluations.

·Utilizing strategic partnering skills, successfully led a 32% reduction in Corporate Audit findings, a 35% reduction in overdue CAPAs and a 52% reduction in “out of box” complaints within one year.

·Achieved certification to ISO9001:2015 and ISO13485:2016.

·Supported gap assessment and readiness activities for EU MDR certification.

DOMTAR PERSONAL CARE, Greenville, NC 07/2012 – 05/2016

Manufacturer of adult incontinence products [class 1 medical devices] and infant diapers.

Quality Assurance Director for North America Personal Care

Responsible for leading the Quality System for the North America Personal Care business (Greenville NC, Delaware OH, and Waco TX). Insuring quality system requirements are effectively established and maintained in accordance with government and customer expectations.

·Achieved ISO9001 and British Retail Consortium (BRC) certification for Delaware OH facility.

·Received certification to UL-R/STR-R’s Retail Certification Program; fulfilling retailer specific requirements for third-party cGMP assessments.

·Reduced % defectives by 34.38%, number of cases placed on hold by 29.68%, and 7.03% decrease in overall complaint rate within one year.

BOSTON SCIENTIFIC, Maple Grove, MN 04/2005 – 06/2012

Leader in Cardiovascular and Peripheral Intervention devices [class 2 & 3 medical and drug-coated devices].

Senior Regulatory & Quality Compliance Manager (7/2007 - 6/2012)

Regulatory & Quality Compliance Manager (05/2006 - 06/2007)

Senior Quality Engineer (04/2005-05/2006)

Responsible for a staff focused on complaint entry, returned device analysis, complaint trending and competent authority communications on divisional Post Market Surveillance activities.

·Collaborating through several company locations, successfully led a corporate initiative to revamp complaint data trending analysis for BSC Global; project status reported directly to company CEO.

·Selected to participate in a task force which resolved an FDA warning letter associated with delinquent customer complaints; resulting in a promotion (May 2006).

·Successfully assisted with the conversion to eMDR.

TYCO HEALTHCARE RETAIL GROUP 05/1999 - 03/2005

Manufacturer of infant/adult diapers, feminine hygiene and wound care [class 1 and 2 medical devices.]

Corporate Senior Quality Engineer (08/2002 – 03/2005) King of Prussia, PA

Responsible for divisional design/process validation program, monitoring customer complaint data and leading multi-site facilitation of root-cause and counter measures as necessary.

·Implemented a new complaint system and a program to electronically track corrective and preventive actions.

·Established and deployed a Cost of Quality program to track spending and opportunities for resource deployment.

·Improved efficiency and effectiveness of acceptance sampling by engineering custom sampling plans to reduce inspection labor, while increasing protection to the consumer.

·Created a forecasting method for complaint data showing anticipated trends

Process Engineer (03/2001 – 08/2002) PARAGON TRADE BRANDS, Macon GA - bought by Tyco Healthcare in 2002

Facilitated teams to assess and problem solve in the areas of safety, product quality, waste levels and efficiency. Coordinated product trials and process upgrades with Corporate R&D and Engineering.

·Resolved a major portion of downtime issues associated with automated vision inspection systems.

·Optimized diaper absorbent core formation and packaging equipment performance by defining the main process parameters, conducting several designs of experiments.

Senior Quality Engineer (05/1999 – 12/2000) PARAGON TRADE BRANDS, Gaffney SC - Site closed in late 2000 and assets later purchased by Tyco Healthcare.

Supervised product testing and Supplier Quality Program. Coordinated product trials and specification development with Corporate R&D. Served as proxy for Quality Manager.

·Established product performance testing procedures and a centralized database for product test results.

·Successfully introduced and designed an automated vendor rating system; reducing claims by 70%.

WALKISOFT U.S.A., Mount Holly, NC 07/1991 - 04/1999

The first North American startup of a European manufacturer of nonwoven roll goods; used in absorbent hygiene and various medical applications.

Quality Manager

Responsible for establishing and maintaining an effective Quality Management System.

·Established an ISO 9000 compliant quality system; achieving ISO 9002 registration for my employer within one year through training and collaboration with peers.

·Achieved a 72% reduction in customer claims within one year.

Previous work history available upon request 09/1987 – 07/1991

EDUCATION / TRAINING

Belmont Abbey College, Belmont, North Carolina

Bachelor of Arts in Business Administration with a minor in Economics

1999 DET NORSKE VERITAS, Houston, Texas

Auditors/Lead Auditors of Quality Systems (ISO)

2000 Kepner-Tregoe Leader Development Institute, Princeton, New Jersey

Certified Problem Solving and Decision Making Program Leader

2001 University of Tennessee Center for Executive Education, Knoxville, Tennessee

Design of Experiments (Professional Development Program)

2003 Tyco Healthcare, Operational Excellence Training Center, Mansfield, MA

Six Sigma Black Belt Training

2005 Certified Quality Engineer (ASQ Certification Number 48529), Minneapolis, MN

2007 Association for the Advancement of Medical Instrumentation, Maple Grove, MN

Quality Systems Requirements and Industry Practice Certificate

2009 British Standards Institution (BSI) Management Systems, Maple Grove, MN

ISO13485:2003, Canadian Medical Device Regulations (CMDRs), European Medical Device Directive (MDD) and Japanese Pharmaceutical Affairs Law (JPAL); Certificate No. 739****-*****

2013 UL/Oriel STAT A MATRIX, Greenville, NC

RABQSA Internal Auditor for ISO13485, Certificate No. 115979

2014 UL/Oriel STAT A MATRIX, Delaware, OH

Exemplar Global Internal Auditor for ISO9001, Certificate No. 116836

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