Quality Engineer

Ana Maria Saaibi M.S., C.B.A

*** ** *** ** *****, FL 33130 email: ********@*****.*** Ph: 504-***-****

Highly skilled professional equipped with wide-ranging background in

engineering, quality and regulatory affairs in both U.S. and international

markets for medical devices and the life-science industry.

OrthoSensor Inc.

Dania, FL (01/01/15-Present)

Director of Quality Assurance

Performed a complete gap analysis and developed a QA and RA remediation

plan to resolve two 483s and

ISO 5 ISO findings and successfully completed them with the Registrar and

with the FDA.

Senior Quality Engineer III

Appointed as Management Representative to develop and implement the quality

and regulatory systems remediation plan. Specifically remediation on

management responsibility, supplier control process, design control process

and design history file management, CAPA, complaint process and regulatory

strategy.

Biomedika Consulting LLC

Miami, FL (09/02/14-Present)

Co-founder

Developed regulatory strategy for Latin American countries on low risk

products. Implemented quality remediation plans for companies in Latin

America to comply with ISO 13485:2003 and local regulatory agencies.

Created and executed process validations and submitted documentation to

regulatory agencies obtaining approval of five products in three countries.

Generated recall action plans in the US and successfully executed them.

Biorep Technologies Inc.

Miami, FL (09/02/08-09/10/14)

Quality Assurance and Regulatory Affairs Director

Successfully implemented the ISO 13485:2003 Quality System and performed gap

analysis for 21 CFR GMP compliance for

Biorep Technologies. Achieved establishment

registration and was appointed official FDA correspondent for listed

medical devices. Selected as regulatory affairs director, responsible for

21 CFR Part 820, 803, 806 and 807 compliance for regulatory submission

documentation and post market surveillance of medical devices.

Developed the regulatory strategy and

created Design History Files, MDD/EU Technical Files, and general quality

records complaint with 21 CFR part 820 for eight medical devices that

launched in the US market in 2012.

Created over twenty five quality procedures and work instructions,

controlled electronic quality records, and performed more than ten supplier

audits to establish strategic partnerships with our contract manufacturers.

Managed customer complaints, and appointed CAPA coordinator, responsible

for root cause investigation and documentation activities.

Design and Development Mechanical Engineer

Appointed lead engineer to work in conjunction with physicians to research

and develop over twenty custom surgical instruments and medical

devices for cardiovascular applications, eight of which are currently in

the U.S. market. Received design inputs, designed initial prototypes,

performed preliminary testing for developed products.

Successfully developed, prototypes,

V&V protocols and executed testing, performed software

validations, developed R&R studies for inspection gauges and conducted and

documented design reviews.

U.S. Food and Drug Administration

Washington, DC (08/10/07-01/08/08)

Research assistant - Center for Devices and Radiological Health

Designed and implemented simulation studies to determine safety thresholds

for regulatory purposes in cardiac Near-Field and Far-Field

Electromagnetism.

University of Florida

Gainesville, FL (01/08/2007- 09/09/2008)

Research assistant - Researched on convection-enhanced delivery in

hydrogels to create computational models. Developed an electromagnetic

computational heart model from diffusion tensor MRI data to compare

differences is tissue response when exposed to electromagnetic phenomena.

Modeled the effects on electrical propagation and defibrillation thresholds

according to myocardial electrical properties.

Intralox LLC

Harahan, LA (01/20/2006- 06/07/2006)

Test and applications engineering intern - Created technical tools,

software programs and tested plastic material properties for specific

industrial applications of modular plastic belting.

Tulane University

New Orleans, LA (05/25/2005 -08/20/2005)

Undergraduate research assistant -Researched on fluid-particle interaction

in blood flow, fluid behavior in formation of thrombus and stent

angioplasty operations.

Masters of Science in Mechanical Engineering and Biomedical Engineering

Minor 2008

University of Florida- Gainesville, FL.

Bachelors of Science in Mechanical Engineering and Mathematics Cum Laude

2005

Tulane University- New Orleans, LA

. ASQ Certified Biomedical Auditor (ASQ 928)

. Certified SolidWorks Associate (C-MZR59HCQ5L)

. LEAD Auditor in Training (RABQSA)

Saaibi, AM, Chang I, Hwang MS, Sarntinoranont M. Comparison Between

isotropic and anisotropic electrical properties of a DTI Based Cardiac

Model, 2008.

. American Society of Quality (ASQ)

. Association for the Advancement of Medical Instrumentation

. RAPS Regulatory Affairs Professionals Society

. Awarded the Oak Ridge Institute for Science and and Education (ORISE)

Fellowship Grant for Research at US. FDA CDRH

. Second Place ASME 2008 Bioengineering Conference MS Student Poster Award

Grand Avenue Software for Quality and Regulatory compliance

iQMS Manufacturing ERP Software

SolidWorks and Enterprise Product Data Management.

Materialise Mimics and 3-Matic

Microsoft Office Package

Qualifications Profile

Profesional Experience

Education

Certifications

Publications

Profesional Affiliations

Awards

Software Packages

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