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Quality Assurance Manager

Location:
Estero, FL, 33904
Posted:
February 22, 2013

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Resume:

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

Theresa Giannakopoulos

Cape Coral, FL 33904

Phone: 239-***-****

abogec@r.postjobfree.com

QUALITY MANAGEMENT SYSTEMS, REGULATORY COMPLIANCE, RISK

DEVELOPMENT

A results orientated, hands-on leader with diverse experience in the manufacture and distribution

of class I non-sterile and sterile Urology, and Gastroenterology devices. Demonstrates innovative

leadership, and comprehensive compliance knowledge in dealing with various regulatory and

governmental agencies. Innovative manager, a strategic thinker, with a “big picture mentality,” has

proven results in startup, implementation and growth environments for company.

CORE COMPENTACIES

Development and implementation of startup Quality Management System procedures,

including MDR reporting, complaint Handling and CAPA. Responsible for medical

device listings, and establishment registration. Directed, developed, introduced, and

executed organization objectives, Collaborated with executive management,

production and engineering in the acquisition of new businesses.

CAPA Program Development QMS compliance for US and ISO Standards

Overseas Supplier Management 510(K)/ Technical File Submissions

Risk Analysis/ Clinical Evaluations ISO 13485, 14971, CMDR and MDD

PROFESSIONAL EXPERIENCE

Ft. Myers Florida – M.C. Johnson Co Inc.,. - February 2009 – June 2012

Quality Assurance and Regulatory Affairs Manager - Completed and assisted in

the contracting, testing and development of new pediatric devices, with a well-known

company to sell in the USA and international. Developed a tactical response to and

interacting with ISO compliance in developing a timeline for robust corrective and

preventative actions including; a total overhaul of the firms Quality Management

System.

Developed a strategic initiative to focus on continuous improvements for the company’

QMS, which resulted a 75% reduction in Notified Body Observations. Responsible for

the continued development of trending and CAPA programs; Hosted an April 2012

ISO 13485 audit, which resulted in a 100% rate of non-conformance’ for the first time

in company history.

Development and implementation of ISO 13485:2003, Risk Profiles compliant to ISO

14971 and ensured a Sterilization program compliant to ISO 11135/EN550 was

maintained.

KEY ACHEIVEMENTS

• Company’ lead for all Inspections.

• Responsible for implementing QMS corrections and liaising with FDA/ISO and

President to vacate a 28+ year-old Consent Decree.

• Responsible for developing a risk plan and gap analysis for all devices, and

responsible for implementing ISO 13485:2003.

• Responsible for preparing and filing 510(k)’s and or exempt.

• Responsible for liaising with practitioners to define clinical applications, evaluations

in the generating of product family risk profiles per ISO 14971 to support device

safety and efficacy.

• Responsible for implementing supplier control techniques including audit programs,

specification developments and quality plans.

• Implemented effective quality review board, and trending tools to provide effective

data to executive management. Responsible for ensuring regulatory compliance of all

products by managing Complaint Investigation, MDR filings and Trend Analysis

systems.

• Implemented ISO 13485 and 21 CFR 820, Responsible for product litigation issues.

• Instrumental in pre-trial site selection, and with marketing, liaising with clinicians

conducting product use evaluations. Responsible for analyzing and formulating

data for regulatory submission.

• Instrumental in the validation of new packaging equipment in preparation for the

transition of products to a new Latin American facility and assisting in the validation

of web based ordering and shipping system to comply with 21CFR part 11.

• Assisted the President in overhaul of purchasing protocols to ensure supplier

compliance.

Lee County Sheriff Deputy

Lee County Sheriff - 01/2003 – 10/2008

CERTIFIED LAW ENFORCEMENT OFFICER

Responsible for the safety and welfare for all of the citizens of Lee County as a road Deputy.

Excellent response and control of high level stressed situations.

Arrested numerous suspects for committing felonies and misdemeanors of various levels.

Caught burglary suspects of occupied dwellings in a timely manner.

• Participated in numerous investigations of felony burglaries of over $5,000.00 which led to

• To the apprehension of the suspects.

• Responsible for the creation of multiple report documentation for court paperwork.

• Recommendation from superiors for the maintenance and order of high level/stressed

• mental inmates.

• Participated in many death scene investigations and assistance of a rape case with the

• Detectives Bureau.

• Conducted group sessions of 20 clients or more on various topics to include Substance

• Abuse, Battered Women Intervention and Anger Management.

• Conducted individual sessions and initial intake psychosocial assessments for walk-in and

• court mandated clients.

• Conducted urinalysis of all court ordered clients on probation and worked exclusively with

• local probation officers in reporting of positive urinalysis and therapy progress of specified

• clients.

• Responsible for the security controls for the main jail and the core building as a control

• officer for the gates and doors of the entire facility.

• Responsible for the booking in of inmates, visitation, inmate property, mail, and

• classifications of the movement(s) of inmates from one facility to another to include four

• facilities. Worked inside the facilities as well as on the Road as a Deputy.

Education

FDLE – Florida Department Of Law Enforcement Academy Ft.

Myers, FL – 2003 - 2008

• Certified Law Enforcement Officer / Deputy

New School University NY, NY

Master of Science - 1997 - 2000

• Degree in Public Administration and Policy to focus on organizational structure and compliance.

SUNY New Paltz

New Paltz, NY

Bachelor of Science – 1993 – 1996

• Political Science with a minor in International Relations and Philosophy, Background courses in criminal justice

Continuing Education:

ISO 9001 with 13485 Lead Auditor Course

BSI, Orlando, FL – 2009-2012

• Lead Auditor

• Complete Audit training for Internal GMP Audits and ISO Audits, in process of MDD but not completed.

References

Available upon request.



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