Christopher Whelan Email & Phone Number

Avon, Ma, Us

Responsible for the registration and listing of the company and products, annually withthe U.S. Food and Drug Administration, (FDA). Submitted 510(k) information, [evidence of substantial equivalence], to the FDA toobtain the ability to market the medical device(s) for interstate commerce. Developed working relationship with notified body regarding European Community (EU) regulations. Worked with distributors to attain regulatory approval of medical devices from Ministries of Health in both EU and non-EU countries, including authentication, legalization and Apostille. Developed and coordinate Sterilization Qualification for ethylene oxide sterilization process performed by an outside contract sterilization vendor. Acted as company representative for all inspections and audits by regulatory bodiesand customers.

Avon, Ma, Us

Structured and maintained Quality Management System in accordance with ISO 13485:2003 to maintain the QMS Certificate. Adapted Standard Operating Procedures to ensure processes are in compliance with best practices and national/international recognized standards. Created requirements for suppliers to adhere to and measured against to be included on the Approved Supplier List. Lead Management Review Meetings semi-annually. Supervised a staff of two Quality Engineers responsible for Process Control, Validation inspection with the Engineering Department and Report Writing. Oversaw three Quality Inspectors responsible for all Incoming, In-Process, Roamingand Final Inspections

Avon, Ma, Us

Worked closely with supervisors and manufacturing personnel to ensure that lower level components are manufactured in time to allow for final assembly, packaging and sterilization prior to satisfying sales orders. Planned with Purchasing that raw materials will be available to satisfy work orders on time. Established the development of manufacturing plans to satisfy forecasts, and then to change the manufacturing plans as forecasts changed. Researched and recommended manufacturing equipment, (turning, molding, cleaning, grinding, laser cutting and welding, finishing, packaging, material handling, inspection and software), to work within purchasing budgets. Collaborated with Engineering, Customers and Doctors to develop product design, validation parameters, manufacturing criteria and assisted with development of an inspection plan. Represent the company in the proper handling, storage, labeling and scheduling of transportation by manifest for all hazardous waste. Coordinated outside training with machine tool manufacturers and set-up/operators to allow for quick implementation of new equipment start-up. Directed manufacturing meetings with representatives from engineering, manufacturing, quality and marketing to ensure all manufacturing requirements are satisfied and then presented that information to the President.

High School Diploma, Machine Drafting & Design

40% Of Courses Completed Toward Associates Degree In Engineering, Engineering