Paused career to provide compassionate care for a critically ill family member.

Supervised the investigation, resolution, and reporting of all adverse events (AE). Processed, investigated, and monitored trending and reporting of product defect complaints. Investigated and resolved complex issues. Served as backup to Product Evaluation Manager. Lead for Byron, Genzyme, and OB tape complaints.• Prioritized information from technical perspective to ensure complaint analysis and investigations were processed in timely manner.• Conducted complaint investigations using device evaluation results including visual standards, root cause analysis, and corrective action decisions.• Reviewed complaint files for accuracy and entered investigation results into database, including observation codes, failure codes, investigation assessment, and summary.Regulatory Compliance• Conducted regulatory reviews of customer complaints; assessed and recorded regulatory reporting.• Oversaw the documentation and resolution of customer reports and complaints in accordance with company policies and procedures to ensure compliance with regulatory agency reporting requirements.• Determined appropriate regulatory reporting requirements, including medical device and vigilance reporting in accordance with ISO 13485, 21, CFR Part 803, European Union MDD/MDR, Brazil's ANVISA, Asia Pacific APAC, Canadian CMDR, and Australia's TGA.Auditing• Assisted with quality system management (QSM) reviews and FDA audits. Provided guidance and assistance to external auditors during official audits.• Served as backroom coordinator during MDR Assessment audit.• Managed and performed monthly departmental file audits.• Maintained and established complaint-handling metrics, SOPs and DOPs.Technical• Facilitated compliant handling process by receiving and entering product complaint information into computer database.• Initiated and established Electronic Submissions Gateway (ESG) with IT.• Assisted with creating access to Canada's SharePoint database.

Conducted phone interviews with physicians, medical staff, sales representatives, and affiliates related to regulatory reporting to obtain Class III medical device complaint information. Generated new complaints in database, including customer, patient, product, surgical, and complaint information, and complaint codes.• Created hard files containing complaint history and patient information, and updated database. • Coordinated no-charge replacement devices and return kits.• Conducted database queries to support complaint and patient failure trend analysis.• Notified management of potential manufacturing or design-related complaints, such as labeling, for investigation and possible escalation.• Coordinated no-charge replacements according to Mentor Lifetime Replacement Policy with international customer service.

Used basic inspection test equipment and determined appropriate tool for measurement to be performed including micrometers, calipers, dial thickness gauges, or microscope.• Read and interpreted drawings, QCICs, and test methods.• Conducted and summarized laboratory evaluations on medical devices through gross evaluation, leak testing, and microscopic examination.• Documented, photographed, assigned lab numbers, and conducted data entry on returned medical devices.