Quality Manager

**** ****** **** . *******, **** *****

Phone 513-***-**** . E-mail ****************@***.***

Kurt Buffenbarger

Objective

To continue my career as a degreed quality

professional with a multi-discipline background

whose emphasis is on delivering world class

quality.

Work experience

[ 8/2012 - Current ] Cincinnati Sub - Zero

Inc., Cincinnati, OH

Quality Specialist

Reporting to the Quality Manager, I am responsible

for the review and approval of all test and

certification processes at this manufacturer of

high end environmental test chambers and patient

warming medical devices. Review and approve design

changes and testing protocols to assure customer

satisfaction and compliance to FDA regulations and

various quality systems requirements. Maintain ISO

9001:2008 and ISO 13485 certification through

internal audits, manage the CAPA program, and

review/audit of suppliers. Review, approve, and

issue Engineering Change Notices (ECN). Coordinate

the Supplier Corrective Action Reports (SCAR), and

compile all information relating to non-conforming

material (NCM). Lead internal auditor and

responsible for the training of all auditors. I

apply statistical analysis to product failure

trends to reduce warranty costs and to improve

CSZ's ability to exceed customer requirements. I

conduct quality training for employees including

5-S, Lean, and current Good Manufacturing

Principles (cGMP)

[ 11/2002 - 6/2012 ] Kutol Products

Company, Cincinnati, OH

Quality Assurance Manager

Reporting directly to the Vice President of

Operations, I oversaw all facets of the company

quality assurance function and its personnel

including incoming receiving inspection, in-process

inspections, and final product release for this

high speed OEM and contract packager of OTC hand

hygiene products and cosmetic personal care

products. Responsible for the corrective and

preventive action (CAPA) program, and the finished

product specification database. Responsible for all

controlled documents, the review and release of raw

materials and manufactured goods used in

production, and finished product inspection

protocols. Managed all the quality aspects of

filling blow-molded bottles, form-fill-seal bags,

pails, drums, f-style bottles, tubes, and gallon

jugs. Conducted OOS investigations. Lead quality

representative for customer and government (FDA

Part 820 and Health Canada) audits. Supervised the

quarantine of non-conforming components

and products and also applied statistical analysis

to determine acceptable quality levels and process

capabilities. Organized non-conformance

investigations and chaired the Material Review

Board. Interfaced directly with customers and

vendors on complaint and quality issues. Organized

and performed internal and external quality audits.

Directed the Design Review function for the review

and approval of new products, packaging, and

labels. Championed the successful establishment of

LEAN quality management principles. I wrote and

performed validation protocols on processes and

equipment. Proficient in MS Word, Excel, and

Outlook.

I was responsible for all the quality related

aspects as Kutol grew from a $20M to a $55M

enterprise, helping to make it one of the fastest

growing hand hygiene/personal care manufacturers in

the country. This included the enormous task of

moving to a new LEED certified facility and all the

related regulatory compliance issues. Directed the

professional development of the quality

technicians.

[ 01/2001 -11/2002 ] Meridian Bioscience,

Cincinnati, OH

Senior Quality Associate

Reported directly to the VP of Quality of this

developer and manufacturer of in-vitro medical

devices. Created and maintained the supplier

quality evaluation program, performed supplier

quality audits, investigated customer complaints,

issued, tracked and trended NCR's and CAPA's.

Project leader for the installation of a CAPA

tracking system (TrackWise by Sparta Systems).

Planned and assisted in cGMP, CFR Part 820, and ISO

training. Reviewed and approved master batch

production records, reviewed IQ/OQ/PQ protocols and

process validations. Reviewed and submitted MDR's

to the FDA. Being the only CQE at Meridian, I was

tasked with the application of SPC to various

manufacturing processes. Initiated the first

FMEA's performed at Meridian. Technical liason for

FDA inspections. Created the company ISO 9001

Quality Manual in preparation of certification.

Member of Material Review Board.

[ 11/1997 - 06/2000 ] HY-Q (USA)

International, Erlanger, KY

Quality Manager

Quality Manager for a leading producer of precision

electronic frequency control devices and

oscillators. Supervised quality technicians and

inspectors and was responsible for all aspects of

product quality conformance. Coordinated all ISO

9001 compliance activities including document

control and policy development. Supervised all

CAPA's. Put into place a computerized CAPA

tracking system. Performed supplier audits.

Responsible for resolving customer complaint

issues, designed and instituted SPC measures,

conducted internal quality audits, created cost of

quality reports. Performed the first Gage

Repeatability and Reproducibility (GR&R) study

conducted at the facility. Maintained OSHA

regulatory compliance and was the plant safety

officer. Performed supplier quality audits and

created supplier certification program.

[ 10/1986 - 11-1997 ] The Jewish

Hospital, Cincinnati, OH

Senior Clinical Engineer

Responsible for the repair, calibration, and

preventive maintenance of over 2000 electronic

medical devices. Performed precision calibration

of adult and neonatal monitors, computer driven

analyzers, telemetry transmitters and other patient

related electronic devices. Performed service on

laboratory equipment at over twenty locations.

Compiled record keeping data on all work performed

for trending and statistical purposes.

Education

Kennedy Western University

Cincinnati, OH

Bachelor's of Science, Mechanical Engineering

Cincinnati Technical College

Cincinnati, OH

Associates of Applied Science, Electronic

Engineering

Associated Skills

Certified Quality Engineer (CQE), American Society

for Quality

Certified Manager of Quality/Organizational

Excellence (CMQ/OE),

American Society for Quality

Certified Bio-Medical Equipment Technician (CBET)

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