Initiate and conduct initial investigation for complaint files, following complaint handling regulation and internal procedures.
Maintain and update database with all complaint activity.
Coordinate with various departmental customers to ensure appropriate resolutions are made.
Initiate and process product reimbursement and claim records.
Maintain a knowledge and understanding of current MDR regulations, guidelines, and interpretations.
Communicate with the Quality Assurance, Clinical Studies, Customer Care, Operation, Marketing departments, and Allergan manufacturing facilities.
Quality Assurance Specialist II, 03/2016 to 08/2019 Dexcom - Mesa
Process and investigate complaints per 21 CFR Part 820 and Standard Operating Procedures (SOP).
Evaluate complaints and assess decision trees to determine if Medical Device Reporting (MDR) is necessary.
Submit MedWatch reports (eMDR) in accordance with 21 CFR Part 803.
Advanced understanding and interpretation of the Quality System Regulations, such as 21 CFR 820, 21 CFR 803, and ISO-13485.
Subject Matter Expert (SME) knowledge of sensor and transmitter related investigations.
Prepare weekly and quarterly metrics.
Support internal, external, and third-party audits.
Writes customer complaints and product investigations, helping to assess risk, identify root cause, CAPA plans, and implementing solutions with business partners.
City Carrier Assistant, 01/2014 to 01/2016 United States Postal Service – San Diego
Delivered and collected mail.
Maintained professional and effective public relations with customers and others.
General knowledge of postal laws, regulations, products and local geography of the area.
Air Traffic Control Specialist, 01/2004 to 01/2011 United States Navy
Excellent on-job-training instructor, which resulted in the qualification of 20 controllers on four operating positions.
Gathered project status reports, coordinated air project schedules, managed air project meetings, and tracked action items.
Developed air project work plans and air plane schedules for assigned projects, scheduled resources and tracked progress.
Organized multiple projects from initiation through delivery with 100% accuracy.
Qualified on four operating positions in minimal time allotted.
Presented numerous training sessions on risk management and safety standards.
Complied with all aviation laws, guidelines and other applicable obligations in accordance to FAA Regulations.
Quickly promoted from E-1 to 3rd Class Petty Officer during time of enlistment.
Earned an Enlisted Aviation Warfare Specialist insignia (EAWS).
Bachelors of Business Administration: 2014 California College - San Diego
Adaptable and self- motivated Quality Assurance Analyst. Comfortable working in a fast paced changing environment, as an individual contributor and active team member. Strong analytical skills with the ability to manage multiple projects at once. Decisive with strong leadership abilities resulting in an immediate impact on business relations. Held US Government Secret Clearance; Honorably Discharged Veteran.
Proficient in Microsoft Office Suite
Knowledge of Operating Systems: Agile, Reliance, TrackWise, SharePoint and Windows