Quality Assurance Manager

Process and System Optimization Quality Assurance and Control Risk Management and Mitigation

Vendor Relationship Management New Product Launch Client Relations

Qualifications Profile

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 instrumentation.

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 2011–2012

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 instrumentation.

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 inputs.

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 review.

Technical Consumer Affairs, Manager, Surgical Instrumentation QA 2007–2011

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 2005–2007

Functioned effectively in performing diverse roles and functions, including:

-Project manager for complaint handling projects

-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, NC

Clinical Team Lead, Satellite Coordinator, and Staff Nurse

United States Army, Durham, NC

Squad Leader, 3274th Reserve Unit

Womack Army Medical Center, Fort Bragg, NC

Staff Nurse (LPN), General Surgical Unit

Education and Credentials

Master of Business Administration, with Concentration in Health Care Management: 2003

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 - 2020)

Registered Nurse, States of California (Valid Until: 2016)

Registered Nurse, States of North Carolina (Valid Until: 2005)

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) Review

-Orange County Disaster Preparedness Academy: ITC Medical Aid Team and Participant

-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

Professional Affiliation

American Society of Ophthalmic Registered Nurses (ASORN): 2003–Present

-Volunteer/Contributing Author for Core Curriculum 2008

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

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