Engineer Quality

Quality focused Mechanical Engineering expert with proficiency at

constructing and analyzing systems in manufacturing environments across

multiple industries to ensure compliance with regulatory standards while

optimizing productivity and efficiency and avoiding costs.

SUMMARY OF QUALIFICATIONS

. PROVIDE ENGINEERING ADVICE AND CONDUCT EVALUATIONS FOR ORGANIZATIONS

REGULATED BY SUCH ENTITIES AS DOD, FAA, FDA AND ISO. PLAN, EXECUTE, AND

SUPERVISE BROAD RANGE OF ENGINEERING PROGRAMS.

. Areas of expertise include systems, facilities, and utilities design,

development, implementation, analysis, validation, preventive maintenance

master plans, Quality System Regulations (QSRs), good manufacturing

procedures (cGMP), IS, and Standard Operation Procedures (SOPs).

. Proven ability to develop and implement complex projects and programs on

time without negatively affecting output or daily processes.

. Industry knowledge includes Aviation, Biotechnology, Pharmaceutical,

Computer Software, Consulting, Defense / Aerospace, Utilities, Gas,

Electric, HVAC, and Medical Devices.

. Registered Professional Engineer and ASQ Certified Quality Engineer,

Biomedical Auditor, and Six Sigma Green Belt. Also recognized as ISO

13485 Certified Quality Auditor.

. Bi-lingual: English & Spanish. Open to domestic and overseas work.

. Managed teams of up to 53 staff members.

Professional Experience

MECHANICAL ENGINEER 01/2010 - 08/2011

HOneywell Aerospace Aguadilla, PR

. Delivered system engineering, configuration and data management support

for naval defense systems, satellites, and space applications.

. Provided advice on Corrective and Preventive Action (CAPA) management and

Material Review Board (MRB) processes regarding nonconforming parts and

material suppliers to Engineering & Manufacturing Departments.

. Supported project management of both civilian and military aerospace

initiatives.

. Performed technical analysis and audits on engineering designs.

Senior field Engineer / FD 10/2007 - 12/2009

Lockheed martin / itt Lajas, PR

. Served as single point-of-contact and control for mission support,

controlled all activities regarding radar systems operations and repairs;

conformed with USAF regulations.

. Conducted investigations on quality systems nonconformities and

implemented corrective / preventive actions (CAPA/CAR).

. Analyzed equipment implementations and modifications and resolved

technical problems.

. Provided technical trainings and briefings to USAF, vendors, and

management representatives.

Information systems Quality Auditor (CONTRACTOR) 01/2006 - 01/2007

Bristol-Myers Squibb

Mayaguez, PR

. Achieved regulatory compliance of Computer System Validation (CSV) and

Information System Management (IM) related to pharmaceuticals

manufacturing; IM Department passed FDA and EC regulatory audits without

incident.

supplier quality engineer (CONTRACTOR) 11/2004 - 09/2005

US Surgical-Tyco Healthcare

Ponce, PR

. Acted as liaison between vendors, Engineering and Quality Assurance

departments to resolve quality problems on parts and assemblies;

performed supplier and internal quality audits; assigned incoming

material disposition using GD&T and SPC techniques.

validation / Process engineer (CONTRACTOR) 06/2003 - 09/2004

sartorius

Yauco, PR

. Developed and executed IQ, OQ, PQ, RQ and FQ protocols for facilities,

manufacturing processes and equipment; in charge of steam sterilization

and drying processes for organic filters manufacturing.

project / validation engineer (CONTRACTOR) 03/2002 - 04/2003

Johnson & Johnson San

German, PR

. Directed on-time completion of FED-STD 209E 100K cleanroom facility

construction within critical pharmaceutical manufacturing area;

maintained uptime of pharmaceuticals manufacturing processes.

. Commandeered construction of PLC-controlled neutralization sump system to

treat manufacturing process wastewater and meet PRASA environmental

regulations; completed on-time and avoided up to $25K/day in government

observations / fines.

. Led internal audit to ensure / demonstrate validation protocols adhered

to cGMPs while maintaining manufacturing process uptime.

INFORMATION TECHNICIAN 01/1998 - 01/2002

US NAVY

Pensacola, FL

. Processed telecommunications using state-of-the-art multimedia

technology, such as fiber optics, digital microwave, and tactical and

commercial satellites; complied with requirements for secure

communications.

. Held SECRET security clearance.

Education And Training

MASTER OF BUSINESS ADMINISTRATION - TECHNOLOGY MANAGEMENT. 08 / 2012

University of Phoenix Savannah, GA

Bachelor of science in Computer & Information Sciences 12 / 2005

University of Maryland University College Adelphi, MD

Bachelor of Science in Mechanical Engineering (ABET Accredited) 06 /

1994

University of Puerto Rico Mayaguez, PR

Professional Licenses & certifications

. Professional Engineer (PE) License - Mechanical.

. ASQ Certified Quality Auditor (CQA-Biomedical).

. ASQ Certified Quality Engineer (CQE).

. ASQ Certified Six Sigma Green Belt (CSSGB).

. HON Design for Six Sigma Green Belt (DFSS).

. ISO 13485 Certified Quality Auditor

professional associations / affiliations

. AMERICAN SOCIETY OF QUALITY (ASQ), PROFESSIONAL ENGINEERS AND SURVEYORS

ASSOCIATION (CIAPR), AND AMERICAN LEGION

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