**** ******* **.

Dover, PA ***** (USA)

Phone: 843-***-**** (Mobile)

e-mail: abmwzg@r.postjobfree.com

Victor A. Gurany (Confidential)

Professional

Profile Bi-lingual (English - Spanish) QA Engineering & Regulatory

Manager with over 10 years of professional experience in

QA/QC, Regulatory Affairs and Manufacturing Engineering areas

as well as Management and Leadership skills managing up to 20

persons with the capability to forge collaborative

partnerships and alliances working and creating a team

environment.

Nationality: U.S. Citizen

Education

1993- 1999 I.T.C.J. Cd.Juarez, Chih. (MEXICO)

Bachelor Degree: Industrial Engineering (Specialty: Quality

and Productivity Systems)

Languages English (100%); Spanish (100%); Italian (50%)

Summary of

qualificatio Additional Education:

ns Quality Management System 16

Hours

ISO 9001:2000 / 13485:2003

Six Sigma (Green Belt Training) 45

Hours

QSR/GMP's (21 CFR Part 820) 32

Hours

WCM (Lean Mfg.)(ITEE) (ITESM) 56 Hours

RAPS Medical Device Certificate Program 120 Hours

(US, EU and Canadian Regulations)

Computer Skills:

Microsoft Office (Excel, Word, Power Point, MS project,

Visio)

AutoCAD R14, 2000; Minitab

Manufacturing Systems (MAPICS, BPCS, JD Edwards)

Equipment & Tooling Knowledge:

Plastic Extruder Machine

Mold Injection Machine

Blow Molding process

Accomplishments

Successfully implemented Quality System for US Operations

based on 21 CFR Part 820, and obtained registration under FDA

as Medical Device Company.

Coordinated the implementation of VMP's throughout the plant.

Audited process control and QA procedures for conformance to

plant, divisional and corporate standards.

Professional

experience Sep, 2008-Present DENTSPLY International - Professional

Division

York, PA - USA

QA Engineering Manager.

Management responsibility: 12

4 Exempt (3 QA Engineers, 1 QS Specialist (Complaints)

8 Non-exempt (QC Technicians)

Direct the quality planning process, develop and implement

continued improvements in Quality System to reduce complexity,

improve effectiveness, efficiencies and productivity.

Manage Quality Engineering, Supplier Quality, CAPA,

Complaints, Internal Audits, Doc Control, Employee Training

and activities including enhanced root cause analysis and

implementation of appropriate corrective actions.

Responsible for develop, implement and maintain quality

standards, policies, procedures and processs meeting

Corporate, ISO, MDD's and FDA requirements

Ensure that new and/or emerging regulatory requirements are

identified and effectively incorporated to the QMS.

Provide the leadership, expertise, and vision to drive improve

d product quality across the site.

Lead (working with Corporate together) on regulatory

submissions and annual/special reports for FDA for Class II

and Class III devices [510(k), and PMA's],

Develops, coordinates and implements self audits,

internal quality audits, coordinates external quality

audits and assures compliance to ISO 13485, MDD's and

FDA (21 CFR Part 820) requirements.

April, 2006-Sep, 2008 GE (General Electric) Healthcare - DI

Florence, SC - USA

QA & Compliance Leader.

Management responsibility: 7

3 QA Engineers; 4 QC Technicians

Lead the product quality efforts across the Florence Supply Ch

ain team.

Prepare regulatory submissions and reports for FDA for Class

II products [510(k as well as other third bodies like

Canadian submissions and CE mark

Maintain Regulatory Affairs product files in compliance with

regulatory requirements.

Provide the leadership, expertise, and vision to drive improve

d product quality across the site.

Ensure the meaningful and timely resolution of CAPA's,

and Complaints.

Work with design, manufacturing, and NPI teams to

drive changes that will reduce quality issues and

result in higher long-term reliability.

Leverage our supplier quality and material resources

to make improvements in the quality of supplied

materials.

Protect the integrity, effectiveness and timeliness of

the change validation process.

Responsible for development, documentation, maintenance,

coordination, & training related to the overall

quality systems for GEHC-Florence.

Develops, coordinates and implements self audits,

internal quality audits, coordinates external quality

audits and assures compliance to ISO 13485, MDD's and

FDA (21 CFR Part 820) requirements.

Lead overall CAPA process for the Florence plant.

August, 2005-April, 2006, WaveLight, Inc.

Sterling, VA - USA

Quality Assurance & Regulatory Manager - US Operations

Management responsibility: 3 QA Engineers

Management Representative for US Operations.

Ensure the Company is in full compliance with the Quality

Management System (QMS)

Ensures that products and services developed by the Company,

meet or exceed quality standards and regulatory requirements.

Provides Senior level quality engineering technical expertise

to organization in the support of new product/process

development, as well as support of on-market products.

Implement the QMS structure (according to FDA regulations and

ISO 13485).

Provide support to currently marketed products as necessary;

including: labeling review, promotional material, product

changes and proper documentation for changes that requires

approval.

Lead any external audits being conduced by regulatory bodies

such as FDA, ISO, UL, OSHA.

Conduct internal audits (in accordance with GxP's, ISO, and

Internal Quality System)

Establish CAPA and Complaint Handling (Including MDR's) as key

elements of the Quality System.

Oversee Document Control function in the Company.

Oct, 2003-August, 2005, Plexus EA. (Contract Manufacturing)

Ciudad Juarez, CH - MEXICO

QA Jr. Manager / Regulatory Specialist (Medical Devices)

Management responsibility: 20 (2 shifts):

2 QA Engineers

2 Doc. Control Coordinators

16 QC Technicians

Regulatory Affairs:

Quality System Regulation [in accordance with FDA Regulations

(QSR 21 CFR Part 820, 806 and 11), ISO 13485 Regulations and

Customer Requirements]

Official Correspondent with FDA

Responsible of the complete Customer Complaint system,

analysis and responses to the FDA (MDR's).

Review regulatory issues and negotiate submissions directly

with agency personnel.

Provide support to currently marketed products as necessary;

including: labeling review, promotional material, product

changes, etc.

Prepare regulatory submissions and reports for FDA, as well as

other third bodies agencies.

Conduct internal audits (in accordance with GMP's, ISO, and

Internal Quality System)

Quality:

Manage inspections of raw materials, materials in process and

finished products.

Assist in the development of quality standards and protocols

for QA

Designs and implements procedures for evaluating the accuracy

of product specifications.

Ensures that products developed by the Company, meet or exceed

quality standards and regulatory requirements.

Provides Senior level quality engineering technical expertise

to organization in the support of new product/process

development, as well as on-market products.

Provides quality support for Non-Conforming Material (NCR) as

well as MRB reviews.

Reviews and Manages Validation Protocols and Reports (IQ, OQ

and PQ's).

Quality Plan / Control Plan development.

FMEA's development

Document Control:

Engineering Change Order (ECO) implementation

Audit and verification of DMR and DHR to ensure accuracy on

documentation.

Spec's, Drawings, BOM's and Procedures Control.

Oct, 2001-Oct, 2003 Cordis de Mexico S.A. de C.V. Johnson &

Johnson Co.

Ciudad Juarez, CH - MEXICO / Miami Lakes, Fl - USA

Sr. Manufacturing / Quality Engineer (Medical Devices)

Management responsibility: 3 QC Analists

Responsible within Eng. department of BU of the following:

Automatic, manual and packaging assy lines

Responsible of Customer Complaints analysis and responses to

the FDA (MDR's).

Responsible of Corrective Actions for all engineering

department. (Analysis and Responses).

Develop and maintenance of manufacturing process including:

Process Validations (IQ, OQ and PQ)/ Qualifications for

equipment and tooling for use in production as well as NPD (R

& D)

Develops manufacturing processes for new products.

Prepares and maintains documentation required to support mfg.

process

Provides engineering expertise to QC regarding Quality issues.

May,1997 - Oct,2001 Mallinckrodt Medical, Inc. (Tyco

Healthcare, LTD)

Ciudad Juarez, CH - MEXICO

Sr. Manufacturing Engineer (Medical Devices)

Management responsibility: 2 Jr. Process Engineers

Responsible of the Manufacturing Engineering department within

a BU.

Process Validations / Qualifications for new processes.

Customer complaints analysis and Quality Strategic Responses.

Provides engineering expertise to QC regarding Quality issues.

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