**** **** **.

Fall River, MA *****

774-***-****

ac2g0j@r.postjobfree.com

Professional Objective

Utilize and advance my skills in post market surveillance, quality assurance and regulatory affairs in the medical device industry and to develop lasting relationships and contribute my knowledge to Fresenius

Education

Northeastern University

Master of Science in Regulatory Affairs Boston, MA

Concentration: Medical Devices, Drugs, and Biologics August 2016

Johnson & Wales University Providence, RI

Bachelor of Science in International Business May 2011

Concentrations: Marketing Management & Sociology

GPA 3.7/4.0

Highlights of Qualifications

Fluent in Portuguese

Trained lead auditor

Work Experience

Quality Engineer II- Post Market Surveillance and Quality Systems- Codman Neuro

Raynham, MA

Nov. 2015- Present

Ensures the adequacy of the documentation of post market surveillance activities in terms of regulatory compliance and technical/statistical soundness

Presents results and proposes escalations, corrective, and preventative actions as required. Leads projects to improve the sensitivity and specificity of surveillance processes.

Creates statistical scripts (code/programs/Excel Macro/workbook) for automation of data driven processes. Collaborates and interacts with other internal teams, including teams representing Manufacturing, R&D, Product Quality, Customer Quality and Supplier Quality. Regularly interacts with upper management.

Creates and maintains all post market surveillance product family plans and review reports for all of Codman Neuro

Ensures daily activities and post market surveillance schedules are complete, accurate and conducted in a timely manner according to procedures and compliance regulations.

Facilitates weekly meetings with cross functional teams within Codman Neuro to assist with non conformances, CAPAs and audit actions that need assistance and to be completed in accordance to the regulatory body standards and corporate compliance

Manages all internal and external (FDA, BSi, TGA and PMDA) audits and the subject matter expert presenting on behalf of the post market surveillance team

Trains colleagues to the post market surveillance and complaint handling requirements by hosing meetings, creating marketing promotional material and creating and revising SOPs to keep up with current standards

Post Market Surveillance and Complaint Handling Analyst Covidien (Medtronic)

Mansfield, MA

June 2013-Oct.2015

Understands the US FDA regulations for Class I, II, and III medical devices regarding Medical Device Reports (MDR s), Adverse Drug Events (ADE's) and complaint handling and reporting based on FDA and International regulations.

Retrieves, reviews, trends, analyzes and reports data using spreadsheets, graphs, and databases to management and other departments.

Interacts daily with customers via telephone and written correspondence regarding post market issues

Coordinates and facilitates incoming contaminated samples for the decontamination process in the lab using appropriate personal protective equipment (PPE)

Facilitates the communication between outside suppliers and the company to improve the logistics, design, and process flow of contracted products

Managing the implementation of a corrective action plan involving our manufacturing plants and the process flow of complaints

Completes product complaint investigations and files Medwatch forms to the FDA for reportable adverse events.

Marketing Promotions Associate - First Glass Promotions Dec.2012-Dec.2013

Hosting liquor demonstrations & tastings throughout Massachusetts

Responsible for promotions of the Senor Sangria line in the Bristol County area

Medical Oncology Secretary/Assistant - St. Anne's Hospital Fall River, MA

Apr. 2008-Oct. 2012

Supervised the medical and radiation oncology file room by training and reviewing work of file room employees

Worked with Microsoft, Mosaiq, and Meditech programs to update patient charts and supply information to the doctors

Responsible for patients confidential files and laboratory results

Marketing Intern - Merchants Overseas Providence, RI

Nov. 2010-Feb. 2011

Helped build social media presence and Internet marketing efforts

Researched potential customers in new markets for Swarovski elements and organized all market research into user-friendly spreadsheets

Coordinated with management to develop marketing plan

Operations Intern - Hasbro Inc. Waterford, Ireland

May 2010-June 2010

Participated in kaizen event to assist with helping to make the material storage facility more efficient

Created a new idea for a software program, labeling and scanning system that would theoretically reduce loss of motion and supply factory space by 53%

Presented newly developed program to senior management for review

Actuated plan currently in use by Waterford facility

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