Quality Manager
Resume:
Dover, PA ***** (USA)
Phone: 843-***-**** (Mobile)
e-mail: *******@*******.***
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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