GARRY L. GAMBILL

ad05up@r.postjobfree.com

**** *** **. ******* *****, MN, 56241, Cell 719-***-****

QUALIFICATIONS

Quality assurance and operations professional working experience in manufacturing mechanical and electromechanical devices, Medical devices, Aircraft, and Automotive. Process knowledge includes exotic or common precision-machined components, stamped, formed metal parts, plastics, and composites. Quality systems implementation skills include ISO, AS9100, GMP, knowledge in Regulatory Affairs, FDA, CE marking. In addition, fifteen years experience in lean manufacturing and training, with multi-site operations, cost reduction and continuous improvement. Additional knowledge in new product launch, SPC, FMEA, PPAP, PQP, MRB, Pokka-Yoke, Root Cause, Gage R&R, GD&T, extensive knowledge and experience working with various computer programs windows, Pro-E CAD ( CREO) Auto CAD and CMM machines, design of inspection fixtures and gages.

EDUCATOR / MENTOR: Manufacturing training curriculum for GD&T, manual inspection and. CMM (Coordinate Measuring Machine) automated inspection FMEA, SPC, ISO/AS/QS, DOE, Engineering processes, Ergonomic, Usability, and Stability.

EXPERIENCE

CNH / Sprayers

Quality Engineering/Inspection Supervisor

5/8/2023 – 8/7/2023

Supervise 11 Quality inspectors final and in process inspection.

Schedule and direct employees on daily task Raw material, CMM, Machine

in-process and final inspection.

Quality Management representative for all quality functions.

Spartanlmp

Quality Engineer

6/23/2021 – 10/28/22

New product development quality manufacturing documentation PLEX.

Work with customers on First article, and PPAP submission.

Work with customers on quality issues.

Develop gage strategy and order gauging.

Represent quality in APQP meetings.

Represent Quality, IATF 16949 and customer audits.

Work with customers OTICS, Toyota, General Motors, and HydroGear as needed.

Pratt & Whitney

Supervisor Quality Inspection / Engineer

2/18/18 – 6/23/2021

Supervise 10 Quality and NDT inspection personnel

Shift change over and assist in supervising 35 production machinist, welders and part finishers

Perform scheduled Quality System Audits.

Perform part defect investigation, disposition, preventive and corrective action.

Maintain employee training

Maintain time on orders using SAP software.

Completed Pratt and Whitney ACE Lean training methods.

Manufacturing Engineer approver and review of Repair station manufacturing process documentation.

Oxford Consulting

Senior Quality Engineer 6/11/17 – 10/15/17

Quality Engineering ST. Teresa Surgiclot dressing market launch.

Development of drug device stability plans.

Development of drug device usability plan.

Worked on documentation submissions for CE Mark and ISO 13485 certification.

SYNTHES / DEPUY, Monument, Colorado (Johnson & Johnson) 6/03 – 5/17

(Manufacturer of surgical implants and devices)

Senior Quality Engineer

Support manufacturing facilities with Quality Engineering issues gage design, validations, and all applicable documentation as required.

Complaint investigation and response.

Work on new product implementation.

Interfaced with suppliers on quality issues.

Programming Zeiss CMM and OGP automated inspection equipment.

Quality training as required.

Assist Engineering, inspection, and calibration staff with gauging or quality related issues.

Design of gages, and perform product analysis using PRO (CREO) Engineer CAD system.

Work on other projects as required supporting Synthes marketing strategies world wide, interfacing with compliance, product development, and management.

Review, and approve IO, OQ, PQ for manufacturing processes.

Responsible for packaging of sterile and Non-Sterile products

Inspection and development of new product and farm out production of implants process implementation, training in-house and at supplier location. Audit of supplier quality system.

Software validation of measuring machine programs and review and approval of aqueous implant cleaning system for sterile products.

Training to the latest Lean standards.

Mutual Tool & Die Inc., Dayton, Ohio 3/02 – 4/03

(Manufacturing, Fabrication, of military and commercial products)

Director of Quality

Manage the quality functions of multiple site projects for military and private applications.

Purchased inspection equipment.

Establish approved supplier system for production, finishing and cleaning.

Worked on lean process and inventory of supplier products.

Implemented ISO 9001/2000, and AS 9100 standards certified BSI.

Interfaced with customers on quality issues.

Maintained calibration system.

Worked with Lockheed Martin on lean projects for manufacturing.

New product development for military, aircraft and heavy equipment support, storage tanks.

R&M Materials Handling, Springfield, Ohio 3/99 – 3/02

(Manufacture of hoist and Crane products)

Operations Director

Managed manufacturing, inventory, parts department, train assemblers, and improved the quality system. Manage 15 employees

Purchased inspection equipment.

Implemented ISO 9000 standards.

Work with Warranty department to improve customer satisfaction

Work with suppliers to reduce cost and eliminate redundant and old life cycle parts.

Implemented Chain Hoist production assembly line with built in test stations for Multi-voltage builds, managed shipping department implementing gravity feed layout and foam expansion packaging, parts department, Engineering, order processing, purchasing and maintained three million dollars in inventory between, France, China and Finland.

MAUCH LABORATORIES, INC., Dayton, Ohio 4/97 - 3/99

(Manufacturer of surgical implants and prosthetic devices)

Quality Assurance Manager

Evaluated, managed (6 employees) ... trained operators and inspectors on Cordax C.M.M., Comparator, and various hand held gages ... in compliance with ISO, GMP, and FDA requirements.

Updated and maintained ISO 9001 standards certification BSI.

Audited and evaluated suppliers and internal systems ... assisted in the design, review.

Interfaced with customers on quality issues.

NORWOOD MEDICAL, Dayton, Ohio 12/92 - 4/97

(Manufacturer of surgical implants, tools, dies, jigs and fixtures)

Quality Assurance Manager

Evaluated, managed and improved the quality system ... this involved setting up the department, ordering all equipment, hiring and training operators on Cordax, C.M.M., O.G.P. vision system, writing manuals and procedures to fulfill GMP and FDA, Manage 3 employees...

Created new building layout punch press, machine centers, inspection lab, cleaning and packaging of class I,II medical instruments new production 8 million in three years.

Interfaced with customers on quality issues.

Implemented ISO 9002 standards TUV registration.

Audited and evaluated suppliers ... assisted in design review / part product evaluation.

Maintained calibration system.

QS 9000, FMEA, PPAP to Automotive customer’s requirements, Delco Remy, Harrison Radiator, International Fine Blanking.

Quality studies, tool and mold qualification for Seamans Industries, Square D, Johnson & Johnson.

Created and maintain supplier quality system for outside finish and production. Created cleanliness standards for supplier finished parts.

SPECTRA-PHYSICS (Laser Plane), Dayton, Ohio 3/88 - 12/92

(Producer of electro-mechanical laser leveling equipment for construction and agriculture)

Quality Assurance Engineer, Supervisor

Supervised quality technicians in first article, work in-process inspection, engineering pre-production, and receiving inspection ... wrote inspection procedures ... utilized geometric dimensioning and tolerancing on new and current production...

Trained shop personnel on coordinate measuring machine and inspection procedures ...in a high volume electro-mechanical manufacturing facility using JIT, and Lean manufacturing principles etc... Programming of Cordax C.M.M. (DCC).

Assisted engineering with the implementation of new product design.

Lean Team Leader for manufacturing projects included manufacture layout implemented point of use inspection reduced production lot size increased inventory turn times base on value stream maping.

ENGINETICS CORPORATION, Dayton, Ohio 10/83 - 3/88

(Government contractor producing brackets and assemblies)

Inspector/Toolmaker

Responsible for first article, receiving, in-process, and final inspection to mil-standards 45208 using random sampling plan 105D ... also handled inspections for General Electric specifications, Pratt &Whitney, Rolls Royce, Kelsey Hayes, etc.

EDUCATION / TRAINING / CERTIFICATION

Kennedy-Western University, Cheyenne Wyoming, Bachelor of Science Engineering… 6/12/01.

R.E.T.S. Technical Center, Dayton Ohio, Degree: Associate / Electronics Engineering Technology, 4/17/92.

Sinclair Community College (Adult Education Program), Dayton, Ohio ... Major: Quality Assurance.

Erico Jones Company ... Completion of Beckwith shop training course inspection methods and blueprint reading …6/78.

Spectra-Physics Company ... Completed courses in Geometric Dimensioning and Tolerancing (scored 100%), training in team participation, certificate of completion in M.I.R. and Front Line Leadership Supervision.

Weber Systems ... Certificate of completion in the use of 2D SYNERGY CAD/CAM System.

ProE ... Certificate of completion in the use of 3D CAD (CREO).

Sheffield ... Certificate of completion, O.F.I. Programming course for coordinate measuring machines.

Off-line programming in Flb (function library C++).

A.S.Q.C. Certification for Precision Mechanical Inspector.

Perry Johnson Consultants ... Completion of ISO 9000:1994 and certified internal auditor course.

MILITARY

U.S.M.C. ... Honorable Discharge ... Duties: Communications

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