Dear Sr. / Madam:

In response to your Sr. level Medical Quality Mgt. position requirement, I have attached a copy of my resume for your consideration. I am in search of a full-time regular employment with a company that value its employees. Traveling on assignment is not new to me and willing to support programs worldwide.

I have over than 30 years of High-Tech Mfg., Quality & Mgt. background working for both OEM & CEM Manufactures managing domestic & international projects (in Europe & Mexico & Asia) such as: Global Manufacturer's Services (Spain), Lambda (USA & Mexico), Burroughs (USA & Mexico), Cipher (USA & Singapore), Comarco (USA, Pacific Rim & China). With exposure to FDA/MDSAP (SeaSpine, Myron L, Accumetrics, Siemens Medical, HeathScan, LifeScan, Ivac, Imed, Alaris), Consumer Electronics, Power supply & Electrical motors, Contract Manufacturing, as well as Mil-Electronics…

My expertise are in high Tech firms with Manufacturing & Quality as well as being a liaison between Manufacturing, suppliers & end-user. Using tools such as Lead Auditor (an FDA certification), Taguchi & PFMEA and Quality tools such as 6 Sigma,SPC, LEAN (Kaizan), ISO9000/14000/13485 and 21cfr820 to simplify requirements for increasing quality of product manufactured at lower possible cost. Over the years, I have developed special skills that would allow me to work with and manage internal customers as well as External customers (in working and/or developing method for generating CaPA, SCAR & 8D report ). Managing suppliers quality both nationally & internationally (Mexico, Europe and ASIA) to work different programs simultaneously to meet targeted deadlines and within projected budget.

As I have shown before my technical preparation combined with my professional experience in fast high tech. industries would allow me to become quickly involve with the type of program your firm will be doing in the near future. Should you require any additional information please do not hesitate to contact me, I may be reached at 858-***-****. Looking forward to hearing from you soon.

Sincerely,

Orang Ezazi

ad2a2b@r.postjobfree.com

858-***-****

PO Box 720534, San Diego, CA 92172

Objective

A full-time regular employment as a Sr. Level Medical Quality Mgt. position for a Medical device organization with emphasis on Quality of product manufactured, FDA compliance, while improving the overall customer satisfaction within forecasted budget.

Employment

1/06 – Present

ISQ, Inc.

Quality Mgt. Contract

Contract consultant, working with clients (both short & long term) contracts in their quality & product transfer needs through iSQi (InternationalSupplierQuality) operations with the following Clients:

SeaSpine, Spine Implant & Instruments OEM ISO13485 / MDSAP

Quality Mgt.

CASE OEM Defense AS9100

Sr. Supplier Quality / Subject Matter Expert

Myron L OEM Both FDA, ISO13485 & Commercial Quality systems

Quality Mgt.

Marway Power OEM AS-9100/ISO900

Technology Transfer Mgr.

General Atomics, Elec Div. OEM AS9100 Defense Contractor

Sr. Program Quality Engr.

Accumetrics FDA-OEM ISO13485 startup company

Quality / Mfg Engr.

Irvin Aerospace AS9100 Defense Contractor

Sr. Program Qualify Mgr.

Maxwell AS9100 Defense Contractor – OEM

Qualify Mgr.

Siemens Medical MRI system ISO13485

Quality Mgt.

Providing technical & managerial consulting skill to clients per the following:

** FDA and MDSAP audit, well familiar with (front & back) room set up for audit compliance

** Knowledge of IPC, ISO9000 13485, FDA 21cfr820 quality STD & Specifications

** TQM, SPC & defect trending (MiniTab), 6-Sigma, Internal & External FDA Audit, Customer quality support (CaPA & SCAR)

** Manage, evaluate performance & develop employee’s relation, team building & team concept to support projects & programs

** Vendor survey & sub-contract management, worldwide Supplier QUALITY, contracting & subcontracting

** Knowledge of supply chain process, supplier quality management program for prim contract purchasing

** Identify& develop new quality metrics as needs rises for R&R gage study and Process Quality report to Mgt.

** Knowledge of product inspection, lot sampling plans & tool calibration program

** International & multi-cultural quality staff Management (in USA, Mexico, Europe and Asia)

** Plans & implements site policies & procedures to ensure efficiency, quality & safety within framework of company guidelines.

** Knowledge of advance High tech. Mfg., Peak & Nano-metaling, 3D printing of titanium, aluminum & SST for medial devices.

** Experience in Developing, Implementing/leading an effective MRB program,

** Experience to lead an effective continuous Improvement Program (Kaizen), projects for Product & Process

** LEAN projects, Product Transfer program

** Plant relocation, factory layout, Time & Motion study

7/04 – 12/05

Somfy

Quality Engr. / Mgr.

Hired as quality Engr. And promoted to Quality Mgr. Working in San Diego design center, I was in charge of all aspect of design certification and qualification, supplier quality and corporate quality from statistical Methods to program quality

1/03 – 5/04

Comarco

Supplier Quality Engr.

Responsible for all aspect of supplier quality working with over 50 suppliers in 11 different countries in Pacific Rim from supplier selection, qualification, ISO audit program, and supplier quality Mgt. Statistical Methods, working with design Engr. to make sure product are producible with quality requirements that could be met.

1/00 – 11/02

Comtel

Engr. Supervisor (MFG, Test, Quality)

Manage over 25 Engr. in MGF/Test/Quality Engr. ISO certification and audit, work with over 30 customers (both FDA and commercial Electronics) in new product releases (over 100 each) throughout the MFG/Ops as well as quality requirements and customer audit.

97 – 99

MSL-Spain

Engr. Mgr. (MFG, Test, Quality)

As a patriot Employee, was assigned for 2 years program in Spain, Manage over 75 Engr. in MGF/Test/Quality Engr. ISO certification and audit, work with over 20 major customers in Europe (both FDA and commercial Electronics) in new product releases (over 50 each) throughout the MFG/Ops as well as quality requirements and customer audit. Corporate reporting on all aspect of Operations

94 – 97

Lambda

Adv. MFG Engr Mgr.& Tech. Transfer

Work with two corporate design centers (SD &NY) in charge or launching product to all manufacturing locations (worldwide). Manage 6 Mfg, Ind. QA Engr. (3 at each location) in creating a smooth transition between design and operations.

90 – 94

Technetics

SMT MFG Mgr. & National Sales Mgr.

Responsible for Mfg. Engr. / SMT operation, from capital equipment selection & justification to creating SOP and operator training. Also promoting the contract Mfg. aspect of the company to potential clients (both FDA and commercial Electronics).

88 – 90

Vernitron

Chief Industrial Engr.

As Chief Industrial Engr. was responsible for all time and motion study, time STD, traveler/router setup factory layout and relocation

85 – 88

Cipher

Sr. Mfg. Engr.

As an SMT Mgr. Engr., responsible for capital equipment justification & procurement, SOP, operator training, sustaining Engr. and new product releases into Ops.

80 – 85

Burroughs

Ind. Engr.

As Industrial Engr. was responsible for plant layout, factory operations, time and motion study

Honors & Achievements

Cipher : Personal award for cost reduction of over $250K

Burroughs : Spotlight person of the month for cost reduction of $100K

A.S.M.E. : First place design winner, for design of a future jet fighter

C.S.A. : Chairman safety committee

A.I.A.A. : Vice President, southeastern Conference

Education

B.S. in Mechanical Engineering; University of Mississippi (1983)

MBA University of Phoenix (expected Dec. 2023)

Certificates in: - Statistics (SPC) - Stress Management

- Lead FDA supplier Auditor - PFMEA, SCAR & CaPA reporting

- Taguchi Method - GDNT certification

- TQM, 6 Sigma - Effective Supervision

- Effective Presentation Skill - IPC 610 certification

- Lean Mfg., Cost Reduction - Kaizan, KanBan

References

References and portfolio will be furnished upon request.

Contact this candidate