Project Manager Engineer

Tammica M. Aguirre

330-***-**** . *********@*****.***

Quality Management

A dedicated professional with over 10 years of experience in a quality

service environment, seeking a management position with an organization

committed to world class service. Considerable strengths include detail

orientation, project management, timeline driven and data collection and

analysis. Excellent interpersonal skills with the ability to work with

diverse groups of people across all levels of an organization. Strong work

ethic with a passion for continuous learning. Competencies:

Quality Improvement Tools CMS/ODH/TJC Regulation

Data Collection ISO 9001

Data Analysis FDA 21 CFR Part 11

Root Cause FDA 21 CFR Part 820

Investigations/CAPA FDA 21 CFR 210 and 211

Customer Complaints

Training and Education Current Good Manufacturing

Excellent Communication Practices

Good Documentation Practices

Problem Solver MS Office Suite 2010 and 2013

Team Skills Six Sigma Black-Belt/ Quality

Engineer

EDUCATION

Currently Pursuing a Master of Business Administration (MBA)

Baldwin Wallace University, Beachwood, OH

Non Degree - Post-Baccalaureate Program, 1997

Howard University, College of Medicine, Washington, D.C.

Bachelor of Science (BS) in Science Psychology, 1996

Minors in Chemistry and Biology

Howard University, Washington, D.C.

PROFESSIONAL EXPERIENCE

Cleveland Clinic Foundation (CCF), Cleveland, OH 2010 -

2014

Multi-specialty academic medical center. One of the top 4 hospitals in the

USA, as rated by U.S. News & World Report. Approximately 44,000 employees,

including 4,600 physicians, residents and scientists representing 120

medical specialties and subspecialties.

Regional 5S Project Manager (Sort, Set-In-Order, Shine, Standardize,

Sustain) 2010 - 2014

Trained Clinicians and Administrative teams in 5S principles

Reduced errors, wasteful activities, and increase safety and

efficiency in the work place.

Implemented 5S in over 30 Cleveland Clinic Regional and Main Campus

Locations

. Managed project plans, measures of success, and deliverables

. Communicated 5S results to all levels of the organization

. Coordinated and monitored the work activities of 500 project teams.

. Worked with sponsors and facilitators to mitigate barriers to project

success.

. Monitored 5S compliance via validation audits and monthly reports.

. Maintained a mean compliance score greater than 85% for total

locations

. Measured customer feedback via anonymous surveys.

Office of Quality - Quality Director

2011 to 2013

. Participated in CMS, ODH, and TJC Surveys

. Developed presentation and communication plan for stakeholders

. Developed a Cause and Effect (Fishbone) Diagram and FMEA for Med Rec

process

. Worked with multidisciplinary team to identify potential failures in

med rec process

. Calculated risk priority numbers (RPN) and identified areas to target

for improvement

. Consulted with Accreditation, Infection Prevention to align

operational goals

. Tracked and reviewed Patient Ombudsman Complaints and Grievances.

. 90 in 90 Initiative to improve HCAHPS scores

. Project to Improve Informed Consent Compliance for Minor Patients

. Project to Improve Compliance to Universal Protocol

. Root Cause Analysis (RCAs) Investigations for Outpatient Procedures

. Developed Action Plans to RCAs to improve Compliance

. Developed annual Quality goals.

. Pre-Survey Readiness Sessions

. Moderated Monthly Quality meetings.

. Monitored CMS and Ohio Dept of Health Corrective Actions

. Participated in Pre-Survey Readiness Activities.

. Documentation Management: Authored SOPs and guidelines.

Assisted with Mortality Reviews

Monitored 30-day Readmissions

Daily Stroke Census, performed daily database queries in search of

new patients

GE X-Ray Target Plant / Kelly Engineering Services, Warrensville, OH

2008 - 2009

A global leader in healthcare technology. Manufacture Component Parts

of X-Ray Machines

Quality Engineer

Performed CAPA Investigations, and Root Cause Analysis

. Managed Document Management System SOPs, Training Records, Supplier

Quality

. Maintained Records from ISO Audits

. Authored and monitored Validation Protocols and maintained Equipment

Records.

Lonza, Inc. and Digene Inc. (Aerotek Scientific), Walkersville, MD

2006 - 2008

One of the world's leading suppliers to the pharmaceutical, healthcare

and life science industries.

Validation Engineer

. Performed instrument qualification activities to assure cGMP

compliance.

. Authored validation protocols and final reports.

. Coordinated validation activities with facilities and internal

customers.

. Conducted Medical device validation testing and data analysis.

. Performed Root-Cause Investigation.

. Participated in FDA and ISO 9001:2000 Training.

Advancis Pharmaceutical Corporation, Germantown, MD

2002 - 2005

A pharmaceutical company that focused on developing and

commercializing novel anti-infective drug products.

Analytical Chemist

. Managed the life-cycle of all finished drug product for Stability

Testing.

. Managed Stability Protocols and testing schedules

. Performed Out of Spec Investigations.

. Analyzed all in-process materials and finished drug products

. HPLC and Dissolution Testing.

. Maintained Good Documentation Practices in accordance with regulatory

requirements

. Conducted Equipment Calibration and Validation activities.

ADDITIONAL CERTIFICATIONS

Continuous Improvement Program: Certified Quality Engineer Training, 2009

Kent State University, Kent, OH

Quality Improvement Program: Six Sigma Black Belt, 2008

The University of Akron, Akron, OH

West Link: Certified Emergency Medical Technician, 1998

Howard University Hospital, Washington, D.C.

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