Manage all complaint handling and post market surveillance activities, including vigilance reporting and product recalls.

Post Market Surveillance

Post Market Surveillance consultant at Smith and Nephew.

Legal Specialist: Review lawsuits for potential complaints. Open new complaints as necessary, prepare MDR files for FDA submission, review complaint files for closure. Coordinate and assign daily assignments, train new employees, review completed work for accuracy.

Device Failure Investigations, MDR and Vigilance Reports, CAPA Coordinator.

Respiratory technical support, complaint handling, tracking & trending

· Design Control: Manage Design Control activities in various stages of product development for 12-15 research projects. Typically launch 5-8 class 1 and class 2 dental products per year. · Successfully implemented a stage-gated new product development process. Create and maintain design history files for all products.· Risk Management: Responsible for all risk management activities for new products. Implemented a risk based post-market surveillance process.· Medical Device Licensing: Prepare and edit 510(k) applications. Maintain and create European and Japanese Technical Files. · Integrated JPAL requirements into the Design Control process.· Audit Support: Provide audit support as a Subject Matter Expert during FDA, JPAL, Notified Body, Corporate and Internal audits.· Process Improvement: Led Kaizon Teams to improve the design control and advertising/labeling processes to reduce rejection rates, allowing products to make it to the market quicker.

Served over 2000 hours as an Environmental Educator and Vol-unteer Coordinator in the AmeriCorps program at Killens Pond and Trap Pond State Parks. Developed programming, recruited and supervised volunteers. Maintained Nature Center.

Worked in the Microscopy and Analytical Chemistry Labs on a part-time basis during the last three years of college. Analyzed defects in returned product and explained results with customers. Developed Standard Operating Procedures for the use of newly acquired laboratory equipment and new analysis methods.

Organized and analyzed data obtained in a research project for Reebok. Created database of statistical and physical calculations.

Collected quantitative data of different strains of the eastern oyster, histological analysis of protozoan parasites in the oysters, and general laboratory maintenance. Molecular analysis was conducted through an independent study project. This included making and performing gel electrophoresis, optimizing Polymerase Chain Reactions (PCR) and preparing them for analysis using mass spectrometry.