Jonathan Degg Email & Phone Number

Goose Creek, Sc, Us

Coordination of healthcare activities and strategic planning with global healthcare leaders. Management of 22 full time & contracted healthcare staff in the US and 9 full time and contracted healthcare staff in Canada as well as the evaluation of healthcare staff qualifications throughout the Americas. Ongoing client auditing as necessary.Qualified as an IRCA Lead Auditor and a lead auditor for ISO 13485, ISO 9001, TL 9000, ESD S20:20, CMDCAS, MDSAP programs and the CE Medical Device Directive.

Responsible in the Americas for the Japanese Pharmaceutical Affairs Law and Risk Management / ISO 14971 processes. Trainer for BSI Americas in JPAL and ISO 14971. Conduct staff reviews and qualification reviews as required. Write Report Reviews (ISO 9001, ISO 13485, CMDCAS, TL, JPAL and CE). Management of large healthcare and telecommunications clients. Monthly delivery of Healthcare KPI report to management. Development of numerous sampling plans. Ongoing client auditing as necessary.

Managed a staff of 18 Client Managers in the Western Region of the U.S. Responsible for the interviewing and hiring of full time and external resource staff, ensuring the delivery of training as well the planning and qualifying of staff and the management of budgets. Ongoing client auditing as necessary.

London, Gb

Manage business partnerships with Fortune 500 companies in the UK and the US to secure the commercial relationship and facilitate opportunities for business development. Assessment of Clients' Management Systems and operating practices against the requirements of various standards - ISO 9001, TL 9000, ESDS 20:20, ISO 13485, ISO 14971 & the BSI Kitemark scheme requirements. Prepare and present assessment reports outlining the findings so that the client is clear about the reasons for the assessment decision and directed to particular items of corrective action where appropriate, recommending the issue, re-issue or withdrawal of certificates, and reporting recommendations to Operations Management as appropriate. Auditing of clients to regulatory requirements i.e. EU Medical Device Directive requirements (including reviews of client technical files (identification of harmonized standards involved, review of product specifications & technical documentation), essential requirements environmental control testing (including biocompatibility, bioburden and particulate levels), Japanese Pharmaceutical Affairs Law & Canadian Medical Device Regulations.

Ricoh is a world leader in the production of Photocopiers. Created and responsible for the operation of an on-going Reliability Test (ORT) System for Photocopiers (based in part on US Military Standard 781D). Supervised a staff of 4 reliability technicians. The ORT process also involved HASS (Highly Accelerated Stress Screening), using various sizes of Environmental Test Chambers (ranging from the testing of a number of Photocopiers to the testing of individual components, for troubleshooting purposes). As part of the new product development process, involved in coordination of Reliability Engineering activities between the UK and the company headquarters facility in Japan, including the use of Environmental Test Chambers for Environmental Testing (a wide range of temperatures & humidity), Vibration Testing, Drop Testing and HALT (Highly Accelerated Life Testing). Involved in quality assurance at all stages in the manufacture of photocopiers, covering various aspects of quality on a moving assembly line: mechanical parts inspection, checking image quality, electrical testing, final cover assembly, final inspection and packaging - involved troubleshooting and repair. Member of the quality assurance team involved in final sampling inspection of production lots of Photocopiers for shipment (statistically based) - from decision, daily lots were shipped or retained if rejected. Process included Hi-Pot testing and resistance checks of all the photocopiers.