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 certification and surveillance audits; provide guidance in interpreting governmental regulations and agency guidelines, including the preparation of… Show more 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 certification and surveillance audits; provide guidance in interpreting governmental regulations and agency guidelines, including the preparation of Pre-Market Approval and 510(k) submissions; support design and development activities through identification of regulatory requirements that must be met; manage the Quality Engineering, Calibration and Document Control functions including the creation of Device Master Records and Device History Records; assure corrective and preventive measures are implemented and controlled; Work with manufacturing and R&D to administer the Approved Supplier program, including supplier qualification, audits, corrective actions and follow up; work with all functions within the organization to identify and implement continuous improvement opportunities. Show less

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 regulations and standards, including 21CFR820, ISO 13485, CMDCAS, MDD and JPAL. Also responsible for developing plans and executing corporate… Show more 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 regulations and standards, including 21CFR820, ISO 13485, CMDCAS, MDD and JPAL. Also responsible for developing plans and executing corporate audits at each site, as well as tracking and trending the results from all audits, supporting audits and inspections from Notified Bodies, electrical product safety inspections and other third party regulatory bodies, including the FDA, as well as other assigned Regulatory support projects. Show less

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 the Patient Monitoring Design and Development Office in San Juan Capistrano, CA. Responsible for a department of 6 salaried and 12 hourly… Show more 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 the Patient Monitoring Design and Development Office in San Juan Capistrano, CA. Responsible for a department of 6 salaried and 12 hourly reports. Serve as Management Representative of the Quality System. Show less

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 and Oncology applications including; stainless steel and plastic molded introducer needles, guide wires, biopsy needles, catheters… Show more 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 and Oncology applications including; stainless steel and plastic molded introducer needles, guide wires, biopsy needles, catheters, hemostasis devices and bio-absorbable biopsy site markers. Responsible for a total of 50 indirect reports at the four separate manufacturing locations. Served as Management Representative for temporary periods at two of the locations. Show less

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 Representative of the Quality System.

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 and anesthesia respiratory circuits with a total plant operating budget of $35 million.Mfg. Mgr, Silicone Catheter Area –Kendall… Show more 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 and anesthesia respiratory circuits with a total plant operating budget of $35 million.Mfg. Mgr, Silicone Catheter Area –Kendall Co.,Tijuana, B.C., Mexico. May 1990 – February 1992 Management of the day to day operation of a department 100 employees in a two - shift operation utilizing silicone extrusion, molding, and hand assembly operations to produce 8 to 24 french Class II Silicone Urological Catheters.Quality Assurance Manager – Kendall Co., Tijuana, B.C., Mexico. July 1988 - April 1990 Management of the day to day operation of a department of fifteen salaried and fifty hourly employees providing in-process product inspection and incoming raw material inspection services to the disposable medical device manufacturing departments through utilization of the Military Standard 105E Sampling and Inspection Plan.Production Supervisor – Kendall Co., Augusta, Georgia September 1986 - June 1988 Third Shift Supervisor for the Materials Processing Department directing 25 hourly employees in the production, conversion and packaging of disposable U. S. P. gauze and wet packaged medical devices.Process Engineer – Kendall Co., Augusta, Georgia August 1983 – August 1986 Process Engineer analyzing all phases of the production, conversion and packaging of disposable U. S. P. gauze and wet packaged medical devices for process and efficiency improvements through the application statistical process control methods. Show less