Diane Kulisek

Past

Member Leader at ASQ (American Society for Quality)
Director, Quality Assurance at Moore Industries International
Forum Participant at In2:InThinking Forum

QA Consultant at Triumph Group - Actuation Systems - Valencia
Founder at CAPAtrak and Quality Warrior
QA/RA Consultant at Implant Direct LLC
V.P. Quality and Regulatory Affairs at Spectrum Laboratories
Quality Director at PTI Advanced Filtration
Sr Mgr QA at DataDirect Networks
Director, QA at Special Devices
Group Manager, Quality Engineering at Gillette
Product Manager, Quality Associate, Avionics & Controls at Rocketdyne, Rockwell International

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9 more...

Education

California State University-Northridge
West Coast University

Recommended

15 people have recommended Diane

Connections

361 connections

Industry

Public Safety

Websites

Diane Kulisek’s Summary

I don't mess around. I get in, get the job done and get out.

Although 'Public Safety' is not a perfect description of my profession, it is often associateed with my role as a quality advocate or quality assurance professional. There was no other LinkedIn industry option that comes close to accounting for what I do (or have done) except, perhaps, government relations.

If you want or need product, process or service quality investigated, corrected, understood, assured or improved, whether from a public safety perspective, a government relations perspective or from a purely economic perspective, I am ready and able to provide you with absolutely outstanding skill and service.

There is a convenient link to a downloadable copy of my resume above or you can download it directly from this url: http://www.capatrak.com/DianeKulisekResume.doc. Please also take a look at the background information provided below, including some very kind recommendations from my colleagues.

I welcome your email inquiry and can be reached at: dkulisek@capatrak.com .

Diane Kulisek’s Specialties:

Quality Advocate, Quality Management System Champion and Strategic Quality Leader, Continual Improvement Facilitator, Process Optimization Specialist, Constructive Change Agent, Organizational Transformation Maven, Performance Metrics Analyst, Quality Engineer, Regulatory Affairs Liaison, Team Builder, Compliance Facilitator for ISO 9001, ISO 13485, AS9100, cGMP, 21 CFR 820, and many other standards, directives, guidance documents and regulations for any and all industries.

Diane Kulisek’s Experience

Member Leader

ASQ (American Society for Quality)

(Non-Profit; Non-Profit Organization Management industry)

February 1981 — November 2009 (28 years 10 months)

Past Division Chair for the Food, Drug and Cosmetic Division; Past Section Chair and current Quality Advocacy Chair for the San Fernando Valley Section of ASQ (Section 706). Former Regional Councilor for the Aviation, Space and Defense Division. Former Deputy Director for the southwestern United States (Region 7). Former certification exam writer for the Quality Engineer and the Quality Improvement Associate exams. Former local instructor for the Certified Manager of Quality/Organizational Excellence Exam preparation course. Current facilitator for the local ASQ "All Certifications Preparatory Study Program".
Director, Quality Assurance

Moore Industries International

(Electrical/Electronic Manufacturing industry)

October 2008 — August 2009 (11 months)

Moore Industries International is a leading provider of process monitoring and control technology for use in nuclear power, petroleum, pharmaceutical, water treatment and food processing as well as other process industries. I led their effort to obtain their trienniel ISO 9001:2008 Certification from UL/DQS, designed and implemented a Quality Intranet Portal for electronic access to a paperless, version-controlled, Quality Management System, baselined key performance metrics and participated in completion of the FMEDA for their newest safety-rated product. I also provided training for the entire workforce on ISO 9001:2008, Root Cause Analysis, Corrective and Preventive Action and a variety of other requested topics. I developed an operator deputization program to transition accountability for inspection to the manufacturing organization. I participated in and acted as the alternate lead for a 'Red Team' to successfully deliver what was reportedly the largest single production order in the company's history.
Forum Participant

In2:InThinking Forum

(Government Relations industry)

2002 — 2009 (7 years )
QA Consultant

Triumph Group - Actuation Systems - Valencia

(Public Company; 201-500 employees; Aviation & Aerospace industry)

July 2007 — March 2008 (9 months)

Provided workforce training and support for compliance with AS9100 and ISO 9001 resulting in maintained Quality Management System Registration; developed Quality Performance Metrics; implemented Document Control and Management Responsibility Operating Systems; including facilitation of Quality Management Review; assisted with Quality Management as Acting Director of Quality during executive search; facilitated AS9102 FAIR compliance in association with facility relocation.
Founder

CAPAtrak and Quality Warrior

(Management Consulting industry)

March 2005 — October 2007 (2 years 8 months)

CAPAtrak LLC was founded with the intention to become a provider of web-based corrective and preventive action systems. When my development partners for that application bailed, I tried to salvage the situation by working as an owner/consultant.... during the worst economic period of history in the U.S.A since The Great Depression. That didn't work, however, I did have more clients than most. Among them were: Johnson & Johnson, Medtronic, Triumph Group, Implant Direct, Spectrum Laboratories and Arbios. You can view a recommendation from the President of Arbios on the 'Endorsements' page of the CAPAtrak website.

There has been no paid work done under the CAPAtrak name since 2007.

I have continued to maintain the websites for CAPAtrak.com and affiliate QualityWarrior.com in order to share free information about quality with my friends and colleagues (because, frankly, right now, understandably, nobody seems to be able to pay for it).

I'm also using the CAPAtrak Blog (www.capatrak.wordpress.com) to keep my name 'out there' on the web, while I'm trolling for my next big gig as a regular employee. You can read my day-to-day comments about quality there now.
QA/RA Consultant

Implant Direct LLC

(Medical Devices industry)

2006 — 2006 (less than a year)

Assisted with 510K submittals to the FDA; provided ISO 13485 Implementation and Regulatory Compliance Support for 21 CFR 820.
V.P. Quality and Regulatory Affairs

Spectrum Laboratories

(Privately Held; Biotechnology industry)

2004 — 2005 (1 year )

This company manufactured hollow fiber filter media, filter cartridges/modules and filtration systems for use in biological research, biopharm and medical device applications.

SPECIAL NOTE: Please see an endorsement from Spectrum's President, Anthony MacDonald, on the CAPAtrak website at: www.capatrak.com (select the "Endorsements" page.)
Quality Director

PTI Advanced Filtration

(Public Company; 201-500 employees; Plastics industry)

2002 — 2004 (2 years )

This company manufactured pleated, spiral wound and flat sheet filter media, filter cartridges/modules and filtration systems for use in automotive, consumer appliance, food, dairy, nutriceutical, semi-conductor and biopharm applications.
Sr Mgr QA

DataDirect Networks

(Public Company; 51-200 employees; Computer Hardware industry)

2001 — 2002 (1 year )

This company manufactured Storage Area Network Data Directors, on a mostly OEM basis, for broadband bit-streaming applications. Clients included Government/Defense, Hospital, Multimedia and Petroleum industries.
Director, QA

Special Devices

(Public Company; 501-1000 employees; Defense & Space industry)

1999 — 2001 (2 years )

Accountable for all Quality Assurance activities for the Aerospace Division, including Project Management, Quality Engineering, Radiography, Process Inspection and Receiving Inspection.
Group Manager, Quality Engineering

Gillette

(Public Company; G; Consumer Goods industry)

1995 — 1998 (3 years )

Worked for multiple divisions of Gilette on separate tours. Divisions supported included Safety Razor (South Boston, MA), Toiletries (Andover, MA), Stationery Products Group (Santa Monica, CA) and Jafra Cosmetics (Westlake Village, CA). Huge injection molding, wet and dry machining, formulation, filling and assembly operations. High speed, high volume, low cost manufacturer. International market and facilities.
Product Manager, Quality Associate, Avionics & Controls

Rocketdyne, Rockwell International

(Public Company; 10,001 or more employees; Defense & Space industry)

1986 — 1995 (9 years )

Primary final accountability was for the Space Shuttle Main Engines, however, covered generic aerospace quality requirements for all programs (Delta, Atlas, Peacekeeper, etc.) as both Supplier Control and Corrective Action & Reporting Manager.

Diane Kulisek’s Education

California State University-Northridge

MS , Engineering - Management Option , 1988 — 1990

Earned BA in Biology, Environmental Option in 1979. Completed Graduate Courses in Environmental Planning through the CSU Consortium on campus at CSUN, as well.

Activities and Societies:

Co-founded Women in Science and Engineering (WISE).
West Coast University

Grad Cert , Program Management , 1988 — 1990

Course was sponsored on-campus at Rockwell International's Rocketdyne Division in Canoga Park, CA.