Linda Torres

• Manage receiving and documentation, coordination, investigation, resolution, and closeout of product quality complaints for generic products manufactured and Contract Manufacturing sites distributed in US Markets
• Complete FDA submissions for Field Alerts for generic products marketed in USA
• Review completed complaint files to assure proper documentation, investigation, resolution, and closeout, striving for full compliance to regulatory requirements
• Support Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives
• Composed complaint and related trend analysis reports for submittal to management to ensure early detection of potential quality issues
• Streamline processes for departmental efficiency
• Ensured quick complaint resolution, actively working to resolve problems efficiently to avoid issue escalation
• Trainer and mentor that guided new recruits in aligning with internal processes and external compliance requirements; led evaluations of QA complaint team members.

• Specialist challenged with identifying and delivering comprehensive complaint triage and resolution for external manufacturing in cosmetics, food supplements, and pharmaceuticals with consistent regulations compliance and quality assurance
• Completed batch releases, non-conformances, and quality change requests, including root cause investigations related to suppliers
• Escalated critical quality issues from suppliers to Senior Quality Management
• Applied sound, systematic problem-solving methodologies in identification, prioritization, communication, and resolution to quality issues
• Tracked quality inputs and identified adverse trends
• Proactively investigated, identified, and implemented best-in-class Quality practices
• Maintained monthly close average of 150 complaints during 2018
• Identified needs for and authored product reference guide, allowing for efficient product identification and accelerating complaint remediation
• Implemented continuous process improvement that streamline daily operations and SOPs, optimizing productivity and outcomes
• Process and Product Subject Matter Expert that coached and trained new-hires
• Initially recruited in contract capacity and was permanently onboarded due to performance and success in complaint investigation/resolution.
• Developed and implemented procedures to meet product quality standards

• Contract role to lead investigations into medical complaints received
• Managed medical data input into safety database
• Executed processing and defined workflow steps of medical complaint information and preparation of internal and external reports
• Communicated with professionals to collect, evaluate, and document information on reported complaints as needed, leveraging medical knowledge, experience and communication skills
• Established full compliance with internal SOPs while maintaining working knowledge of safety guidelines and requirements
• Seamlessly managed 75 cases per day for global direct consumer medical device complaints, including intakes, reviews, triages, follow-ups, assessments, information accuracy, integrity checks, file audits, regulations compliance, and final closures
• Led assessment of documentation for seriousness and criticality, escalating accuracy complaints, circumventing further issues; report ability to U.S
• FDA and European Economic Community (EEC).
• Skilled at working independently and collaboratively in a team environment

• Contract role challenged with efficient review of product documentation and trending data. Developed fully compliant and detailed complaint records. Processed and analyzed global medical device complaints with strict regulations compliance, SOP adherence, and comprehensive information intake and analysis. Processed customer complaints within specified timelines in accordance with US and international regulatory requirements and company policies. Established reports for prompt review of new complaints, regulatory reporting decisions, and follow-up. Reviewed, prepared, reported, and submitted FDA Forms 3500/3500A.
• ● Owned full responsibility for ensuring all required information for complaint file was obtained and properly documented to make sound regulatory reporting decisions.
• ● Evaluated all information from clinical and technical perspective to ensure appropriate analysis, investigation, root cause, and quality engineering review is documented prior to complaint closure.
• ● Leveraged complaint handling and quality engineering expertise across full cycle of medical device complaints
• Increased efficiency and team productivity by promoting operational best practices.
• Followed-through on all critical inter-departmental escalations to increase customer retention rates.
• Trained new personnel regarding company operations, policies and services.

• Performed regular quality and validation assessments on patient data to verify accuracy.
• Studied and researched various medical terms as well as software and coding systems.
• Generated medical reports on patient admissions, treatment and discharge for disbursement to various departments.
• Conducted quality improvement and customer satisfaction surveys to evaluate patient care.
• Processed product complaints with SOP and FDA regulations compliance, timeline efficiency and accuracy using global complaint and TrackWise databases

Prepared and summarized investigation for product complaint case conclusions

Hired as customer service specialist in 1987 and received consecutive promotions through systems analyst.

• Resolved or escalated problem tickets to resolve user issues.
• Installed system updates to address vulnerabilities and reduce security issues.
• Developed diagrams to describe and lay out logical operational steps.

Triaged average of 100 complaints daily with full compliance and accuracy; entered information into databases

Closed approximately 75 complaint cases per month after delivering full-cycle complaint management (intake through

closure) with cross-department collaboration

Completed comprehensive annual systems validations and on-going system enhancements validations

Initiated quality method for complaint database entry process, increasing accuracy from 70% to 100% Differentiated product inquiries and product complaints for accurate delivery to departments and manufacturers