Quality Assurance Manager

RESUME

Robert L. Gillispie

*** *. **** *.

Provo, Utah 84601

801-***-**** (Cell)

Email: abh9sz@r.postjobfree.com

PROFESSIONAL

OBJECTIVE:

To be a versatile team member of an Operation, that believes in continuous

improvement while providing opportunities for long term growth and

development.

EXPERIENCE:

Worked with several companies to upgrade and improve the daily operations

of their quality systems and managed Quality Assurance, Quality

Engineering, Inspection, and Quality Planning. Special projects for these

and other companies in an outside consultant capacity have been included:

0. Complaint Manager over customer complaints/recalls and perform

Divisional Regulatory Compliance audits, world wide

1. Well versed in US (ISO9001-2000, ISO13485, 21 CFR 803, 806, 820, 210,

211, QSR), Canadian (CMDR), PAL (Japan), European (MDD), and Latin

America reporting to the respective Competent Authorities

2. Sr. Quality Engineer over several product lines of BD medical devices

3. As a team member of various validations, I reviewed IQ, OQ and PQ data

for quality acceptance

4. ISO9002 Company Management Representative, certified Phoenix 9/01 and

two more sites by 4/02

5. Managed a department budget of $2.3 million dollars, with gross sales of

over $250M

6. Managed a department of 54 people of which five were Quality Engineer's,

five Quality Technician's, one CMM inspector, and 43 quality auditors

(this was my largest group)

7. Total Quality Management Training, Six Sigma green belt and Lean

Manufacturing training

8. Authored and Implemented various company Quality Manuals and procedures

9. Customer, FAA, FDA and Government interface for audit and inspection

requirements

10. Interfaced with Customer, FAA, FDA, and Government representatives as

well as in-house inspectors/auditors on various inspections and audits

(ISO9001-2000, ISO13485, 21 CFR 820, QSR, MIL-I-45208, MIL-STD-45662, MIL-

Q-9858, Boeing D1-9000, QS-9000 and FAR)

11. Supplier Audits

12. Surveillances

13. Source Inspections

14. Receiving Inspections

15. First-Article Inspections

16. In-Process Inspections

17. Final Inspections

18. Quality Audits (Over 100 internal, external and supplier)

19. OSHA/CALOSHA audits

20. Government Source Audits and Inspections

21. Working knowledge of FDA QSR and cGMP's concerning medical devices and

plastic injection/blow molded parts

22. Introduced, trained, and facilitated the Statistical Process Control as

a Boeing Advanced Systems Certified Instructor.

23. Worked with Engineering to review customer specifications, engineering

drawings and documentation for preparation of inspection criteria and

conformance to customer and Government requirements

24. Reviewed purchase requisitions for applicable quality and customer

requirements

25. Reduced incidence of product defects through statistical process

control methodology to enhance ROI

26. Established and maintained a computerized in-house calibration system

for mechanical and electronic test and inspection equipment

27. Contract Review for Quality Requirements

Product Experience

28. Medical devices

29. Semiconductor equipment refurbishing

30. High speed turbine pumps

31. Plastic ejection and blow molding

32. 2-cycle and 4-cycle engines

33. Machine shop and sheet metal parts

34. Mechanical and Electronic Assemblies

35. Aircraft Parts and Assemblies

EDUCATION

. BS. Business Management/ Quality Assurance

University of LaVerne (Vandenberg AFB) 1990

CERTIFICATIONS

. BD Medical certified auditor for ISO13485 and 21 CFR 820

. Lead Auditor of ISO9001:2000 (Perry Johnson)

WORK HISTORY:

2/02-10/10 Sr. Quality Engineer (2002-2003) / Manager, WW Complaint

Handling (2003-present)

BD Medical

9450 S. State St.

Sandy, UT 84070

12/00-2-02 Manager, Quality Assurance, North America

BOC Edwards Kachina

3925 E. Watkins, St. 100

Phoenix, AZ 85034

3/98-11/00 Manager, Quality Engineering

Ryobi Outdoor Products

550th N. 54th St.

Chandler, AZ 85226

In addition to the above positions, I have been in quality since 1984 and

have held many quality positions from receiving inspector to Quality

Manager and a consulting position of Director of Quality and Operations

Support.

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