Christopher Watkins Email & Phone Number

Saudi Arabia

One of the key notified bodies working with the governmental SFDA regulatory agency, advising on the approval of Medical Devices imported into the Middle East. Focusing on the GHTF Regulations.Managing and maintaining an efficient department with staff that includes European as well as Saudi Arabian nationals. Advising the SFDA on all Technical and Regulatory matters.Supporting the infrastructure and approval process between SFDA and Importers of medical devices from around the world.

Mountain Ash Uk

Quality Director for all manufacturing based in Flexicare Medical.Included manufacturing sites in both UK and China.MHRA representative for queries and post market surveillance.Company representative for other world regulatory bodies such as FDA and Irish Regulatory bodies.Representative for MHRA Pharmaceutical division concerning Medical Wholesale Licence.

Mountain Ash

Officially appointed the RP person by the MHRA Pharmaceutical Division Design and implementation of the company's market vigilance program Direct negotiation with FDA on submission requirementsManaged multi-disciplinary teams to bring about sustainable business improvement in areas of Regulatory, Quality and New project Introduction.Responsible for registering medical devices in countries across the globe.Company representative for all customers on Quality and regulatory affairs. Managing Regulatory bodies, all customers and suppliers around the globeSuccessful implementation of Pharmaceutical Wholesale License for Drugs.Successfully passed a manufacturing audit by the FDA on the company’s China plant in 2013.Introduced product registrations into various countries around the globe.Implemented statistical techniques to improve and develop understanding of manufacturing variation and hence quality improvements, both in UK & China.Responsible for implementation of engineering practices and new product introduction.

Departmental Head of Quality Assurance.Manufacturing of First and Business Class Seating.Customers covering both Airbus and Boeing.Form 4 HolderPart 21 G QualifiedPart 21 J QualifiedPart 145 Qualified

A temporary assignment to review the practical and Strategic Quality position of LINPAC.Identified the necessary KPI's to be used by each department and implemented a monitoring system which included Cost of Quality.Coached the company personnel in the successful tools and techniques that helped improved the company's relations with its customers.Identified and provided recommendations to enable the company to improve its right first time performance.Communicated existing issues and recommendations to senior management to improve performance. All recommendations accepted by management and corrective action plan implemented.Changed shop floor Quality controls from product inspection to process monitoring.

Introduction of site Business Plan for China site. This included Company Strategy, Departmental Objectives as well as Departmental KPI'sResponsible for the Quality implications of product line transfers to the China plant. Planned the Quality activities to maintain customer expectations while conducting the downsizing of an Australian and European plant in line with corporate strategy.Successfully managed the customer approvals for all production line transfers.Successfully implemented TS16949 accreditation (Feb 2007)Managed the cost saving project of localisation of European supply chain to China.Introduced both System Audits as well as Product & Process Audits to monitor KPI's as well as Quality Standards.Worked with site Operational Directors, Engineers, Sales and Quality staff to ensure successful implementation and improvements of all projectsImplemented and acted as leader for the monthly BOR (Business Operating Review) meetings across all sites. Reported findings and actions to Management Board level.Designed and implemented a Supplier Development Program to improve Quality, Delivery and Cost. (£68,000 saving results from project)Monitored and improved customer satisfaction though PPM reduction. Set up and managed a Testing Laboratory to enable the company to validate new platforms in AsiaManaged the company's biggest costs saving program "Introduction of Chinese wiper motors". This resulted in an annual saving of £ 284,424.

Pontypool

Developed strategy for improving relationships with customers while reducing external PPM from 650 to 66. Introduced a Quality strategy to slim line facilities and reduce costs.Submitted cost saving ideas which resulted in over £250,000 savings per annum.Key team member for the implementation of the Johnson Electric Motor into the Trico linakage system.Successfully removed four General Motors CSL 2 activities within 6 week time frame.Successfully co-coordinated the transfer of the department in line with company relocation strategy.

Managed the project team for the successful implementation of TS16949 Developed the Quality System within the company including the introduction of a computerised quality system to QS9000.Successful implementation of ISO 14001 in 2001 for Tredegar Plant.Key player, introducing Global Quality Strategy into Tenneco.Developed and run the Tredegar Plant strategy meetings.Improved key measures from 820ppm to 40 and zero on some customer plants.Reported to Group European Quality Director.

Carried out maintenance activities on ISO 9001 procedures together with the successful completion of three surveillance visits and the successful implementation of QS9000.

Managed the internal auditing team for the successful implementation of QS 9000 and ISO 14001. QS9000 was assessed at Trico in March 96 and approved without any major or minor non-conformity. - Worked for several months in Japan on the introduction and design of new products into the Japanese market place.

The design and monitoring of a new quality system on the Greenfield site - Company Training Officer - Responsible for designing and implementing a company wide training program.

Supervised and coordinated the activities within the Goods Inwards dept. Previous experience consists of an Engineering Apprenticeship with HYMAC Ltd, Rhymney. Extensive experience on various heavy machining practices, also won several apprenticeship awards.

Engineering Apprenticeship

Biocompatibility Of Medical Devices, Pass

Regulatory Requirements

Clinical Evaluation For Medical Devices, Pass

Regulatory requirements for medical devices

The Eu Regulatory System For Medical Devices, Pass

Regulatory Requirements

Overview Of Us Fda Quality System Regulation, Pass

Understanding how the FDA organisation works and how to register products and undergo an audit.

Overview Of Us Fda Quality System Regulation, Pass

Understanding how the US FDA works

Iso 14971:2007 Risk Management, Pass

Management of risk with medical devices

Molecules, Medicinces And Drugs

Health And Environmental Management 2009

Mba, International Business

Education record

Education record

Diploma, Management

Education record