Quality Manager

Ron Kirby

*** ****** **. ***. *

Arroyo Grande CA 93420

805-***-**** *******@*****.***

PROFILE

** ***** ** *********** ********** managing and maintaining Quality Systems

in the medical device and aerospace industries. Practiced in ISO 9001, ISO

13485, AS9100 and 21 CFR - Parts 820 Quality Systems Management and

Auditing. Well versed in all aspects of production, inventory control,

scheduling, receiving inspection and maintenance.

Key Accomplishments

Quality / Production Management

. Implemented, managed and maintained quality systems for aerospace and

medical device manufacturers - ISO 9001:2000, ISO 13485:2003, AS9100

. Developed and implemented Receiving Inspection criteria and supplier

quality monitoring. Reduced inspection backlog from 120 days to 5

days.

. Improved product quality > 30% through process improvements and

training enhancements

. Assigned delegated source inspection responsibilities for Boeing, BF

Goodrich Aerospace, Lockheed Martin, Northrop Grumman and Sargent

Controls. This was achieved through product and process quality

improvements.

. Served as Management Representative and Certified Internal Auditor

. Key site contact for CAPA and Customer Quality issues

. Improved production efficiency 15%, cross training, lean manufacturing

techniques

. Decreased overtime 30%, team building and elimination of redundant

operations

. Established Work-Center meetings with production and engineering staff

to improve communication of process and quality related issues.

. Maintained schedule adherence, 5% above corporate goals

. Critical Team member of new product release (HD Camera System), > 40%

improvement in product quality over previous generation

. Implemented Lean Manufacturing concepts, Line reorganization

. Established data collection and tracked yields for production /

supplier quality. Presented data at quarterly Management Reviews Work

History Highlights

Work Experience:

Zodiac Aerospace 2013 - 2014

Quality Engineer / Production Manager

Responsible for manufacture and quality of the production of First and

Business Class seats for Boeing and Airbus. Compiled production and quality

data for Management presentation and review. Managed 190 people, 5

supervisors and represented Zodiac on customer related quality concerns.

. DPU reduction of 70%

. 100 % schedule adherence

. Saved company 70 k monthly converting to ocean shipment.

. Participated in AS9100 internal and external audits.

. Created Quality Requirements for inspection of assembled units

Materion - Thin Film Coating Group 2009 -

2013

Quality Assurance Manager -

Directed activities in Quality System Management, Final/Receiving

Inspection, Supplier Quality and Customer Complaints for sites in Buellton

CA, Westford MA and Windsor CT

Materion specializes in anti-reflective and infra-red coating applications

in the defense, medical and commercial industries.

. Established formal Receiving Inspection process and Supplier Quality

tracking

. Primary contact for Supplier Quality and responsible for MRB and RMA

actions

. Use of measuring microscope, calipers, optical comparator, Varian

spectrometer, MIL specification for optical components, specifically

optical glass and germanium.

. White Belt trained and member of Green Belt team focusing on Non

-Conforming material.

. Improved vendor feedback process through the use of digital

documentation and Excel spreadsheet data development.

. Managed and trained Internal Audit team. AS9100, ISO13485 and ISO9001

. ISO Management Representative for all sites

ConMed - Linvatec Endoscopy Division 2005 - 2008

Quality Engineer / Production Manager

Responsible for Quality System and Product compliance to ISO 13485 and 21

CFR

Equus Computer 2003 - 2004

Quality Specialist

Managed and maintained ISO 9001 Quality System.

Laminated Shim Co 1995 - 2003

Quality Manager / Production Manager

Managed and maintained ISO 9001 Quality System - Aerospace components.

Norstan Electronics 1993 - 1995

Receiving Inspection / Quality Manager

Managed and maintained MIL I 45208 Quality System and Inspection Department

Laser Magnetic Storage 1979 - 1990

Production Manager

Managed the assembly operations of a computer drive manufacturer

Education / Certifications

Job-related training includes team skills, group problem solving,

performance management, statistical process control, gage capability,

production control, and inventory management.

Riverside Community College

Quality System implementation, SPC, system auditing. Student of

Distinction 2001

Lockheed Martin - Statistical Process - ISO 9000 and AS 9100 - 1997

ISO9001:2000 Internal Auditing, Qatel and CALISO -Certificates available

2003 / 2004

ISO 13485:2003 and 21 CFR Parts 820 Internal Auditing - Noblitt & Rueland -

2006

Leadership Development Program - Eckerd College 2008

AS9100 Internal Auditor - 2011

Received Executive Management Excellence Award - 2013 Zodiac

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