Quality Control Assurance

Gagik Voskanian

** ****** ******

Watertown, MA. 02472

Tel: 617-***-****

Email: ******@****.***

Objective:

Challenging position in Quality Systems in FDA/ISO regulated (GMP, GCP

regulations), medical, electronic or digital device manufacturing

industries as a QA internal /external auditor, compliance specialist, QC or

manufacturing supervisor.

Personal:

. Reliable, innovative, exacting in compliance and quality control.

. Detail oriented. Good written and oral communication skills.

. Interfacing well with all levels of technical and operational

management.

. Effectively interact with employees in a cross-functional team

environment tasks and projects.

. Concurrently handle a variety of tasks and projects.

. Familiar with electronic devices and use of hardware and software

tools to build and configure computers.

. Extensive knowledge of Microsoft Word, Excel and Access.

. Have taken training for QA Partner.

. High integrity and moral values.

Employment:

Boston Scientific Inc. Natick, MA Aug 2007 -

Oct 2008

Senior Compliance Auditor CAS (Corporate Audit Support) -(Contract)

. Performed Audit Support activities to support all audits conducted by

FDA, Notified Body Registrars, and 3rd Party Consultants, across the

Corporation.

. Involved in Start-up activities associated with the Corporate Audit

Support group.

. Responsible for all logistical tasks associated with preparing for

audits, supporting audits, and post-audit activities.

. Responsible for report writing and generating metrics associated with

audit requests.

. Other responsibilities also included, process improvement projects and

updating and maintaining of critical information on the CAS Intranet

Website.

GEHC (General Electric Health Care) - Salt Lake City, Utah (Contract)

May - July 2007

Reviews, verification, generate reports and closure of Corrective actions

(CAPA) resulted from FDA investigation.

Hyaluron Inc., Burlington, MA (Contract)

Jan - April 2007

QA Lead Auditor - On Contract basis conducted Vendor qualification site

audit and Internal audits of Hyaluron Inc., assuring compliance to QSR, ISO

13485 and internal SOPs. Report audit findings to management, CAPA

investigations (Review of Validation reports and Batch records) and

closure.

ConMed Inc., Billerica MA (Contract)

April - Dec 2006

2005 - 2006

Process Engineer - Performing transfer of documents/ SOPs/drawings.

Preparation of ECNs, BOMs, Creation of Preventive Maintenance Documents for

Tools used in manufacturing, Tooling Documentation, Assisting with IQ,PQ

documentation.

Review of First article reports from suppliers.

Manufacturing (Clean Room )Supervisor - Managing the manufacturing of new

product in a clean room environment, assuring compliance with internal and

GMP regulations on manufacturing floor (Assuring QC accepted material on

manufacturing floor is kept separate from rejected or failed components

during manufacturing following Guidelines). Supervising a staff 13

manufacturing technicians.

Reviewing batch records and lot release.

Performing MRB/Disposition and corrective action related to non-conformance

material/product.

Crystal Clear Communications, Inc., Woburn MA Dec 2002 - March

2006

District Manager - AT &T Wireless Authorized dealership-Initial set up of

locations. Managing main office and several retail locations throughout

Massachusetts. Managing Inventory / Returns/ Complaint documentation and

processes, employee training procedures, Payroll and Commission setup.

PAREXEL International Inc., Waltham MA Jan 2001 - Feb 2002

QA Auditor II

. Performed internal audits of various types (Sponsor, Data, System,

and Central Files) according to internal SOPs, GCP and ICH and ISO

guidelines.

. Initiated notifications and generated audit reports to management and

auditee.

. Participated in two (2) FDA mock audits.

C.R. Bard, Electro Physiology, Lowell MA Sep 1984 - Nov 2000

Compliance Specialist and Quality Control Supervisor 1995 - Nov 2000

Manage the Internal Assessment (Audit) of Quality Systems:

. Developed audit schedule, performed audits (internal, vendor/supplier

and other divisions) per FDA regulations (GMP, QSR, and ISO 9000

guidelines).

. Prepared and generated audit reports to management and conducted

follow-ups till closure.

. Participated in the development of solutions to non-compliance.

. Provided training when necessary. Maintained audit and corrective/

preventive action (CAPA) database. Issued, monitored and provided

periodic reports on status.

. Participated in CE marking of products.

. Assisted in the Quality Systems training of employees as needed.

. Updated/revised departmental and divisional policies (SOP) as

required.

Supervisor- Quality Control Department:

1992 - 1995

. Ensured controlled, receipt and release of raw material (computer

related hardware-i.e. boards, modules, cables, etc.) through Incoming

Inspection and final product lot release practices.

. Identified and evaluated Non-conformance, generated material review

reports (MRR), conducted MRBs, implement CAPA and reported status

periodically.

Accomplishments

. Minimized non-conformance in quality systems to unprecedented levels

of efficiency.

. Developed a database using MS Access for tracking audit findings and

CAPA.

. Increased productivity in compliance & quality control through the

development of creative systems.

. Managed conflicts with recognized customer & diversity focus.

. Participated in FDA audit of the facility and was complimented on

record keeping.

Associate Software Q. A. Eng.

1989 -1992

Testing and validation of Lab System (Duo) EP Laboratory application.

. Manually tested data integrity and verified previously recorded as

well as real-time data. All tests adhered to FDA and ISO regulations.

. Performed in-depth unit testing of specific areas of product, as well

as performance of various hardware components.

. Authored "Instructions for Use" for software installation of the

product.

Accomplishments

. Improved software performance and augmented manufacturing

productivity.

Technical Supervisor (hardware & software)

Configure and test manufacturing software/hardware

. Built, configured and integrated software/hardware on various computer

platforms.

. Tested printers, monitors and all finished product per approved E-

Specs, using electronic tools (i.e. Multi-meter, signal generator, scope

etc.)

Accomplishments

. Achieved higher rate of productivity.

Technical Supervisor- (Research and Development)

Prototyping & process development.

. Initiated component and engineering specs for configuring hardware.

. Created BOM (Bill Of Material).

. Purchased components.

Accomplishments-

. Superior Quality Assurance.

Education:

University of Lowell (BA Psychology) Lowell, MA

Middlesex Community College (AS Electronics) Bedford, MA

Accreditation:

Certification for accredited lead auditor with specific reference to the

medical device industry-FDA Quality System Regulation [21 CFR part 820]-

[Excel Partnership, Inc.]

Certification for internal auditor training for FDA regulated industries-

[Excel Partnership, Inc.]

Certification for Quality System Regulation for medical devices [ASQC]

Certification for Quality System Auditing to ISO-9000 standards [ASQC]

Referrals: Upon request

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