Quality Assurance Manager - Healthcare Resume Search
Quality Assurance Manager - Healthcare Resume Search
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Quality Assurance Manager Resume

Desired Industry: Healthcare SpiderID: 75974
Desired Job Location: North Richland Hills, Texas Date Posted: 8/12/2015
Type of Position: Full-Time Permanent Availability Date: Immediately
Desired Wage: 125000
U.S. Work Authorization: Yes
Job Level: Management (Manager, Director) Willing to Travel: Yes, 25-50%
Highest Degree Attained: Masters Willing to Relocate: Yes

Highly analytical, solutions-focused,
and multifaceted healthcare
professional, equipped with solid
medical product information experience.
Adept at implementing and maintaining
policies and procedures, quality
assurance process management, developing
safety programs, and developing medical
information proposals. Known for
expertise in evaluating medical product
processes, systems, or technology
changes that bring forth productivity,
optimize efficiency, and reduce costs.
Equipped with outstanding communication
and interpersonal skills; capable of
maintaining relationships with a multi-
disciplinary network of individuals.

Professional Experience

Alcon Global Medical Affairs, Fort
Worth, TX ~ 2003–Present
Global Medical Product Information Lead
– Surgical 2012–Present

Proactively administer medical content
development for surgical franchise,
while managing surgeon mentor program.
Identify and escalate complex
situations, including development of
escalated complaint investigation
requests and documentation solutions.
Efficiently organize off label HCP
process instructions (sample handling,
reprocessing) for surgical
Serve as Medical Inquiry call center
surgical trainer, facilitating
instruction on disease state and
surgical product portfolio.
Leveraged industry expertise in
developing and maintaining best-in-class
medical information proposal.
Designed IOL characteristics inquiry
support, in accordance with medical
standard guidelines.

Senior Quality Assurance Clinical
Analyst, Surgical Instrumentation QA

Played a key role as a project manager
in handling international service call
product complaints.
Organized and facilitated cross-
functional clinical decisions and
process meetings.
Took charge of conducting annual and ad
hoc risk management updates for surgical
Acted as primary contact for clinical
customer inquiries in escalating issue
or documenting resolutions.
Instituted 11 clinical position/white
papers to clearly define process
decisions across organizations.
Demonstrated efficiency in establishing
and executing global harms process to
maintain up-to-date risk management
Established and implemented customer
satisfaction metric for instrumentation
product service to lessen large service
call volume.
Functioned effectively as surgical
instrumentation lead for SPC Global
Quality Complaint Early Detection
project, as well as clinical lead for
site-wide quality system management

Technical Consumer Affairs, Manager,
Surgical Instrumentation QA 2007–

Administered and evaluated complaint and
trend information on all surgical
instrumentation, accessories, consumable
and new product releases as the
management representative.
Managed clinical event investigations
and complaint risk management activities
in relation to reported clinical events
and instrument malfunctions.
Served as facility lead for global
complaint system and associated business
intelligence systems for Alcon’s first
comprehensive global application.
Expedited global complaint handling
process for both medical and quality
complaints in accordance with applicable
global regulations, affecting products,
processes, practices, and procedures.
Expertly utilized technical clinical and
engineering resources to ensure timely
implementation of projects; thus
enhancing complaint handling processes,
risk management, metric automation, and
compliance activities.
Effectively formulated processes and
procedures for global regulatory and
complaint-handling activities for
surgical instrumentation.

Quality Assurance Clinical Analyst

Functioned effectively in performing
diverse roles and functions, including:
Project manager for complaint handling
TCA management representative designee
for quality system management review
Core development team member for global
complaint system
Quality clinical lead and
Customer/clinical consultant

Earlier Career

Alcon Surgical Instrumentation Quality
Assurance, Irvine, CA
Senior Consumer Affairs Analyst

Pitt County Memorial Hospital,
Greenville, NC
Staff Nurse, Registered Nurse in Cardiac
Surgery Intensive Care Unit

Eastern Carolina Eye Center, Greenville,
Clinical Team Lead, Satellite
Coordinator, and Staff Nurse

United States Army, Durham, NC
Squad Leader, 3274th Reserve Unit

Womack Army Medical Center, Fort Bragg,
Staff Nurse (LPN), General Surgical Unit

Master of Business Administration, with
Concentration in Health Care Management:
East Carolina University, Greenville, NC
University Health Systems: Executive
Administrative Residency

Bachelor of Science in Business
Administration, Concentration in
Management: 2001
East Carolina University, Greenville, NC

Associate of Science in Nursing: 1997
Pitt Community College, Winterville, NC

Diploma for Practical Nurse, US Army,
Fort Sam Houston: 1995
Emergency Medical Technician, States of
Texas (Valid Until: 1995)
Certified Registered Nurse in
Ophthalmology, American Society of
Ophthalmic Registered Nurses (2003 -
Registered Nurse, States of California
(Valid Until: 2016)
Registered Nurse, States of North
Carolina (Valid Until: 2005)

Professional Affiliation

American Society of Ophthalmic
Registered Nurses (ASORN): 2003–Present
Volunteer/Contributing Author for Core
Curriculum 2008

Process and System Optimization ~ Quality
Assurance and Control ~ Risk Management
and Mitigation
Vendor Relationship Management ~ New
Product Launch ~ Client Relations

Additional Information:
Professional Development

DIA: Medical Information Certification
American Heart Association: Advanced
Cardiac Life Support
Joint Commission on Allied Health
Personnel in Ophthalmology: Certified
Ophthalmic Assistant
Orange County Regulatory Affairs: US
Regulatory Affairs Certification (RAC)
Orange County Disaster Preparedness
Academy: ITC Medical Aid Team and
International Organization for
Standardization (ISO): Quality
Management Systems Auditor/Lead Auditor
(QASNA ISO 9000:2000 Series)
International Organization for
Standardization (ISO): Plexus ISO 14000
Training System (ISO 14000 and Internal
EMS Auditing Modules)
University of California Irvine: Medical
Device, MDR Instructor Resource |
Medical Device Development
US Army: Primary Leadership Development

Technical Acumen

Clinical Data Research: (PubMed, OVID
and NLM) | Food and Drug Administration
Site Searches: (Maude and MedSun)
TrackWise | EasyTrak | Cognos BI |
JDEdwards | Catalyst | Adobe Acrobat X |
Reference Manager | Crystal Reports
Microsoft Office Suite | MS Visio & PM|
CATSweb | IRMS | Documentum | Windchill
PLM | Siebel | SnagIt | Impromptu

Available upon request.

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