Christopher Mooney Email & Phone Number

Bluffton, SC, US

Woburn, MA

Responsible for assuring the OPKO Diagnostics Quality Management System complies with the requirements of FDA 21CFR and ISO13485:2016 requirements. Responsibilities include: serve as Company Management Representative for the Quality Management System and interface with FDA and Notified Body during all scheduled FDA Inspections and Notified Body.

Skaneatles Falls, NY

Regulatory Affairs Global Audit Manager:Responsible for the implementation the Internal Audit program for Welch Allyn sites in Skaneateles Falls; NY; Beaverton, OR; Tijuana, MX; Jungingen, Germany; Navan, Ireland and Singapore, including ensuring that internal audit plans are established and maintained at each site, in compliance with applicable.

Utica, NY

Administration and management of the Quality Assurance Document Control, Internal Auditing, Quality Engineering Corrective and Preventive Action and Sterilization Lab Services functions supporting the ISO 13485 Compliant Quality System for manufacturing facilities in Utica, N.Y. and Chihuahua, Mexico, as well as the Distribution Center in Atlanta, GA. and.

Syracuse, NY

Administration and management of the Regulatory Affairs and Quality Assurance functions of four separate manufacturing locations located in the U.S. and Denmark employing a total of 600 employees and with annual sales of $80M. The four locations are involved in the development and manufacture of components and finished devices for Interventional Radiology.

Syracuse, NY

Administration and management of the Quality Assurance, Research & Development and Equipment Engineering departments and functions, as well as the maintenance and improvement of the company’s ISO 13485 compliant Quality System for a 200 employee manufacturing operation. Responsible for a department of 6 salaried and 20 hourly reports. Served as Management.

Augusta, GA & Tijuana, Mexico

Process Improvement Administrator – Kendall Co., Tijuana, B.C., Mexico March 1992 – Jan. 1995Facilitator of the continuous improvement process that resulted in improved quality, service and lower product cost for a Maquiladora operation of 700 employees producing Class II anesthesia, urological and diagnostic procedural trays, silicone urological catheters.

Bachelor Of Science (B.S.), Chemical Engineering

Activities and Societies: Intramural sports (football, basketball, wrestling); Set up 1 week Spring Break Trip for 60 students to Daytona.

Bachelor Of Science (B.S.), Chemistry

Activities and Societies: Intramural Sports (Football, Basketball, wrestling); Chemistry Club; Study & Work Chemistry major in the.