In this role, I implement, communicate, and maintain the company’s quality systems at the facility in compliance with Marken’s Global Quality Management System (QMS) requirements. I interact with clients on Quality Assurance (QA) and Good Practice (GxP) related matters and collaborate effectively with Marken departments and stakeholders to ensure all QA tasks are appropriately supported. I oversee an internal audit schedule, perform internal audits, and manage associated corrective and… Show more In this role, I implement, communicate, and maintain the company’s quality systems at the facility in compliance with Marken’s Global Quality Management System (QMS) requirements. I interact with clients on Quality Assurance (QA) and Good Practice (GxP) related matters and collaborate effectively with Marken departments and stakeholders to ensure all QA tasks are appropriately supported. I oversee an internal audit schedule, perform internal audits, and manage associated corrective and preventive actions (CAPA). Additionally, I audit external service providers as part of the vendor selection process and track commitments from previous audits. I host client audits and regulatory inspections, manage audit report responses, and act as Marken’s main representative. My responsibilities include managing issues and CAPA plans, identifying quality improvement initiatives, overseeing CAPA close-outs, and delivering GxP/Quality training. I manage change control and ensure the Marken Quality System and GxP Program are maintained. I assist in evaluating vendors and outsourced activities, ensure the accuracy of records and documents, monitor personnel training, coordinate recall activities, participate in internal quality meetings, and keep informed of regulatory changes, updating SOPs as needed. Show less

In this role, I prepared and submitted post-market reports and submissions, including Medical Device Reports (MDRs) and Medical Incident Reports (MIRs). I maintained systems to trigger and log regulatory reporting and tracked and managed files related to annual licenses, registrations, and listings. I also managed systems to track, manage, and report product-associated events, including complaints and recalls. My responsibilities included identifying sources for local, regional, and global… Show more In this role, I prepared and submitted post-market reports and submissions, including Medical Device Reports (MDRs) and Medical Incident Reports (MIRs). I maintained systems to trigger and log regulatory reporting and tracked and managed files related to annual licenses, registrations, and listings. I also managed systems to track, manage, and report product-associated events, including complaints and recalls. My responsibilities included identifying sources for local, regional, and global regulations, collecting and organizing regulatory intelligence, and monitoring the regulatory environment. I provided information for evaluating proposed products' regulatory classification and jurisdiction, researched requirements for regulatory submissions and compliance, and assisted in developing regulatory procedures and standard operating procedures (SOPs). Show less

Field Actions Coordinator (2018-2022), I provided primary support for Field Action (FA) activities, collaborating in both voluntary and mandatory recall processes to ensure efficient management and regulatory compliance. I participated in recall strategies, including effectiveness checks and reporting, and coordinated pre-FA activities, managing the FA watch list and assessments. My responsibilities included obtaining data from subject matter experts, preparing FA presentations and customer… Show more Field Actions Coordinator (2018-2022), I provided primary support for Field Action (FA) activities, collaborating in both voluntary and mandatory recall processes to ensure efficient management and regulatory compliance. I participated in recall strategies, including effectiveness checks and reporting, and coordinated pre-FA activities, managing the FA watch list and assessments. My responsibilities included obtaining data from subject matter experts, preparing FA presentations and customer letters, and securing necessary approvals. I worked with Marketing to distribute FA support packages, prepared regulatory agency reports, and managed agency communications and responses. Additionally, I maintained FA records, tracked regulatory commitments, and communicated project goals to the Business Unit, ensuring functional FA infrastructure support. I played a key role in audit preparedness, document management, and maintained professional knowledge of global regulations, continually optimizing and improving processes. I also provided high-level support during internal and external audits and performed various related duties as required.• Complaint Handling Analyst (2014-2018): I received and processed escalated product complaints and customer feedback from both internal and external sources, ensuring compliance with medical device laws and regulations. I assessed complaints to determine if adverse event or vigilance reporting was necessary and evaluated complaint information for completeness and accuracy, providing recommendations for process and product improvements. Additionally, I identified critical product issues and escalated them through the quality system for appropriate actions, such as Field Action, CAPA, Supplier Corrective Action, or Stop Shipment activities. I effectively communicated within project teams and departments to ensure the completion of key deliverables and analyzed complaints, instrument, and patient data to identify patterns and trends. Show less

Perform elementary blood banking and clinical laboratory procedures in hematology, immunohematology, clinical chemistry, serology, bacteriology, parasitology and urinalysis. Collect blood specimens by venipuncture and capillary puncture. Pack, unpack, inspect, store and distribute blood and blood products. Assemble, disassemble and maintain laboratory equipment.Awards:The Army Commendation Medal - Meritorious service as an MLT at the United States Army Heidelberg Health Clinic. April… Show more Perform elementary blood banking and clinical laboratory procedures in hematology, immunohematology, clinical chemistry, serology, bacteriology, parasitology and urinalysis. Collect blood specimens by venipuncture and capillary puncture. Pack, unpack, inspect, store and distribute blood and blood products. Assemble, disassemble and maintain laboratory equipment.Awards:The Army Commendation Medal - Meritorious service as an MLT at the United States Army Heidelberg Health Clinic. April 2013.Good Conduct MedalNational Defense Service MedalGlobal War on Terrorism Service MedalNon Commissioned Officer Professional Development Ribbon Show less