Quality Assurance Director - Medical Devices

Consult Search & Selection ,
London, Greater London
Job Type: Full-time

Overview

Quality Assurance Director - Medical Devices Salary dependent on experience plus bonus and attractive benefits package Some travel required The Company My client is a successful medical devices business with an impressive product portfolio selling products in over 130 countries. As part of their global growth plan, they have created the exciting new position of Quality Assurance Director, to be based out of a new London office and supporting Quality Assurance strategy across Europe, the Middle East and Asia. The Opportunity This is a really unique opportunity to branch out this successful organisation's Quality Assurance function from the US into the UK. With excellent knowledge of ISO13485, MDD, MDR and FDA regulations, as Quality Assurance Director it will be your responsibility to defining and implementing quality assurance programs in Europe, Middle East and Asia. You will oversee all quality assurance activities for outside US subsidiary offices and act as primary QA contact with all outside US third-party distributors. Responsibilities include: - Driving improvement to the Quality System to expand outside the US. Developing processes and detail procedures to ensure an effective Quality System. - Developing and optimising post market surveillance processes. - Leading the establishment of appropriate quality systems to meet global internal and external quality system requirements. - Developing effective and constructive solutions for corrective and preventive action. - Identifying and communicating global best practices. - Developing and communicating trend analyses to identify and address key compliance risk areas. - Overseeing the creation and maintenance of agreements between the EU importer and the EU distributors who will be placing the devices on the market. Overseeing EU Importer duties at the Amsterdam location. - Maintain communication with Competent Authorities and Notified Body as necessary. About You To be considered for this post, you should demonstrate experience with: Quality Assurance Management from a medical device company People management Experience in working in a multinational company with global responsibility Apply Today Or Contact Sophia at Consult Search & Selection for more information