Diane Kulisek

Current

Director, Quality Assurance at Moore Industries International
Founder at CAPAtrak, LLC / Quality Warrior
Member Leader at American Society for Quality

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Past

QA Consultant at Triumph Group - Actuation Systems - Valencia
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, Stationery Products Group
Product Manager, Quality Associate, Avionics & Controls at Rocketdyne, Rockwell International

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5 more...

Education

California State University-Northridge
West Coast University

Recommended

13 people have recommended Diane

Connections

275 connections

Industry

Electrical/Electronic Manufacturing

Websites

Diane Kulisek’s Summary

My goal is to provide effective support to individuals and organizations striving to enhance product or service quality.

Diane Kulisek’s Specialties:

Heavily Regulated Industries such as Aerospace and Defense (DCMA, FAA, NASA), FDA-regulated (Medical Device, Pharmaceutical, Nutraceutical, Food, Cosmetic) and, most recently, Nuclear (NRC) and Consumer Product manufacturing; metal fabrication, plastics and assembly operations; Quality Management Systems (ISO, cGMP, QMS), Quality Performance Metrics and Strategic Planning, Corrective and Preventive Action (CAPA), Customer Relations, Supplier Control and Qualification.

Diane Kulisek’s Experience

Director, Quality Assurance

Moore Industries International

(Electrical/Electronic Manufacturing industry)

October 2008 — Present (10 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.
Founder

CAPAtrak, LLC / Quality Warrior

(Management Consulting industry)

March 2005 — Present (4 years 5 months)

CAPAtrak LLC is a contract-based service provider of Quality Assurance services. Current and recent clients include or have included: Johnson & Johnson, Medtronic, Triumph Group, Implant Direct, Spectrum Laboratories and Arbios. Diane Kulisek is founder of the company, however, due to her new engagement as Director of Quality Assurance for Moore Industries International, work is confined to assignments that do not represent a conflict of interest and for which work can be performed outside of regular work hours. Diane will refer some assignments to highly-qualified professional colleagues upon request.
Member Leader

American Society for Quality

(Non-Profit; 51-200 employees; Computer Software industry)

February 1981 — Present (28 years 6 months)

Current (2008-09) Chair for the Food, Drug and Cosmetic Division; Current Quality Advocacy Chair, Web Master and Historian for the San Fernando Valley Section of ASQ (Section 706) and Past Section Chair. Former Regional Councilor for the Aviation, Space and Defense Division. Former Deputy Director for the southwest (Region 7). Former certification exam writer for the Quality Engineer and the Quality Improvement Associate exams. Local instructor for the Certified Manager of Quality/Organizational Excellence Exam preparation course.
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.
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

(Public Company; 51-200 employees; Medical Devices 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 "People" 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, Stationery Products Group

(Public Company; 10,001 or more employees; 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.