Quality Assurance Manager

David M. Bagdasarian

603-***-**** *********@*****.***

Highlight Summary

What's in the "Bag"? I offer 29 years of extensive experience in

diversified mechanical & manufacturing fields, including 7 years in

specialized machine shops, and 22 years in Quality Assurance/Control. Work

included various mechanical machines, injection molded & extruded

components, assemblies & fixtures, precision inspection equipment, plus ink

jet/bar code printers in the commercial field. Knowledge encompasses most

specialized processes used in machine tooling trades, commercial

manufacturing, FDA regulations, military specifications, medical

applications (ISO 13485), ISO-9001 2008, plastic injection molding, as well

as most phases of QA/QC programs.

Professional Experience

Innovative Medical Design

Nov 2013 - present

Ayer, MA

Quality Manager

. Create Quality Management System to support future ISO 13485

certification

. Maintain calibration of in-house instruments/gages and coordinate

external gages for calibration and/or repair

. Inspect incoming and in-process materials and assemblies and generate

necessary supporting documents

. Accountable for follow-up and trending of internal and customer non-

conformances/complaints

. Oversee CAPA and NCMR database

NT Medical (Contract roles)

- Sept. 2010 - Nov 2013

Wilmington, MA

Quality Specialist (layoffs/slow sales)

. Perform quarterly internal audits and participate in yearly

surveillance audit

. Provide testing and inspection of all submitted 1st articles, in-

process molded components, sub-assemblies

and incoming goods

. Review all customer paperwork, certificate of conformances, invoices

and necessary lot history for accuracy

. Evaluate, monitor, trend and disposition all internal and customer

rejects/complaints

. Maintain CAPA, NCMR and Complaint database; generate quarterly reports

. Maintain calibration of in-house instruments/gages and coordinate

external gages for calibration and/or repair

Rochester Precision Optics - Plastic Optics Division (6 month contract -

relocated to NY)

Manchester, NH

Quality Assurance

. Responsible for writing company forms, work instructions and procedures

in anticipation of ISO 9001-2008 (registrar recommended certification)

. Review and perform 1st article and final audit of all outgoing finished

plastic optics to ensure product and paperwork meets customer

specifications

. Evaluate any product return from outside sources/customer and

determine corrective/preventive action and measures

. Responsible for equipment & calibration program

GT Advanced Technologies (7 month contract - shifted operations oversees)

Merrimack, NH

Supplier Quality Engineer

. Work closely with Engineering, Management, Production Control and

other personnel to communicate quality issues

. Direct communication with outside vendors to resolve any supplier

related issues

. Responsible for reviewing and generating work instructions and

procedures

. Trained to conduct first article of received goods and to generate

written Power Point evaluation and accurate reporting

. Assist Returns Specialist with RMA's, Quality Notices and problem

identification and corrective action

IMD Medical (5 month contract - group ownership dissolved)

Amherst, NH

Quality Engineer

. Perform internal ISO audits, participate in yearly surveillance audit

& make necessary changes to work instructions/procedures

. Review and evaluate CAPAs for closure and determine effectiveness

. Audit all outgoing manufactured medical components & related paperwork

. Monitor all suppliers for performance to required medical industry

standards & issue corrective actions

. Successful in ensuring the company met ISO requirements to

successfully pass yearly surveillance audit

Nu-Cast

May 2010 - Sept

2010

Londonderry, NH

Quality Inspector

. Perform first article layout/inspection of prototypes and finished

product/aluminum castings

. Inspect and disposition all returned products from sub-contractors for

outside processes

. Generate vendor notices regarding corrective action/preventive action

. Perform scheduled internal ISO audits

. Monitor rejected components and assign proper disposition

Summit Packaging Systems

Feb 2002 to April 2010

Racine, WI

Q.C. Managing Supervisor

. Oversee seven Q.C. subordinates and communicate departmental goals

following ISO guidelines

. Manage calibration lab and reduced external calibration of equipment

by 60%

. Incorporate employee awareness resulting in 80% less turnaround time

of internal rejects/rework

. Revamp the sampling program while maintaining quality levels

. Responsible for 1st article, in-process and final inspection of

plastic components and finished aerosol valves

Scan-O-Matic

Feb 2001 to Sept. 2001 Racine,

WI

Quality Assurance Manager

. Develop Quality manual, procedures and records for ISO 9000-2000;

works towards obtaining certification

. Perform inspection using precision measuring instruments and C.M.M.

. Set-up calibration lab to calibrate precision measuring

instruments/equipment following ISO guidelines and

acquire necessary equipment

. Work with department Supervisor/Manager/Coordinator to develop process

control plans, streamline inspection processes,

and revamp the sampling program while maintaining quality levels

Education Additional Training

Carthage College, Kenosha, WI - BSI Lead Auditor Certificate

- Commercial Art - ASQ Member 1993-present

Western Wisconsin Technical Institute, LaCrosse, WI - Master

Supervisor Certificate

- Technical Diploma - Machine Tooling Techniques

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