Medical Device

Stephanie Glatts, RHIA, BSN Complaint Specialist

*******@*******.*** 267-***-**** Media, PA

Ethical professional with Bachelor of Science in Nursing and significant experience investigating and resolving customer complaints. Adept at using detailed product knowledge to execute thorough complaint assessments in compliance with corporate quality standards. Skill processing and analyzing complaints following standard operating procedures and regulatory requirements. Analytical capable of effectively switching between either large-scale or detail-oriented approaches to achieve success.

Areas of Expertise include:

Complaint Analysis & Resolution

Internal Audits

Data Review

Risk Management

Documentation

Trauma/Surgical Nursing

Trends Analysis

Medical Record Review

Professional Experience

Merit Medical Systems, Inc • Malvern, PA • 2013 to August 2018

Field Assurance Clinical Specialist

Negotiated suitable resolutions to medical device complaints, performing quality investigations and preparing detailed reports. Analyzed trends and performed risk assessments and audits of potentially hazardous devices and situations. Supported audit activities, implementing Corrective and Preventive Action (CAPA) system review and analysis of complaints. Recommended remediations to FDA, ensuring compliance with current FDA/QSR, ISO13485, CE Marking, and other appropriate product guidelines.

Key Accomplishments:

Led continuous process improvements to quality management activities, implementing and maintaining Pilgrim (quality management software); trained users on software.

Streamlined operations, simplifying complaint intake and global adverse event reporting processes while remaining compliant with regulatory requirements.

Managed quality improvements, closing 90% of complaints within 30 days.

Crozer Chester Medical Center • Chester, PA • 2005 to 2013

Staff RN Trauma/Surgical/Telemetry

Assessed and managed care for patients with life-threatening illnesses and high-risk heart and lung disease complications. Administered care for post-operative and multi-symptom-injured trauma patients. Provided critical care, managing airways, conducting vascular checks, and monitoring cardiac and trauma events.

Key Accomplishments:

Specialized in high-level patient monitoring, serving as preceptor for new nurses to ensure safety of all patients.

RMS Corporation • Allentown, PA • 2001 to 2004

Healthcare Reimbursement Specialist

Managed healthcare records, performing comprehensive reviews and ensuring accuracy of diagnoses, procedures, and co-morbidity conditions and complications. Assigned correct ICD-9-CM codes to all inpatient records.

Key Accomplishments:

Conducted quality reviews of DRG assessments to ensure accurate recording of principle diagnosis and procedures according to Uniform Hospital Discharge Data Set guidelines and AHA Coding Clinic publications.

Ensured coding accuracy, clarifying clinical issues with appropriate hospital departments and/or physicians.

Optimized reimbursement for all contracted facilities.

Temple Lower Bucks Hospital • Bristol, PA • 2000 to 2001

Tumor Registrar

Registered and maintained records of patients treated for cancer, abstracting pertinent clinical data for staging, diagnoses, and treatment. Reviewed and monitored case identification and completed reports.

Key Accomplishments:

Identified and compiled patient data on reportable conditions from range of relevant sources; reported to Department of Health.

Maintained Tumor Registry System compliant with Pennsylvania Cancer Registry (Department of Health) regulatory requirements.

Education

Bachelor of Science in Nursing

Drexel University • Philadelphia, PA

Bachelor of Science, Health Information/Medical Records Administration/Administrator

Temple University • Philadelphia, PA

Contact this candidate