We have the pleasure of working with a leading Medical device manufacture who is looking to strengthen their quality and regulatory compliance function by seeking an experienced quality professional to work within their sales and services business across Europe.

The role will be task to develop and implement a regional wide quality system and focus of driving compliance across the group where you will be responsible for managing group wide projects, whilst managing internal and external audits as well as being the group’s focal point for all compliance issues,
 

A summary of this role’s responsibilities includes, but not limited to;
 

• Management, support and further development of the employees in quality management for the development of integrated management processes
• Planning, implementation and further development of the quality management system DIN EN ISO 9001, 13485, FDA QSR 21CFR820, corporate quality management system and other relevant legal and normative conditions
• Consistent further development of the quality principles and strategies as well as the quality goals
• Supervision of the specialist departments in sales and service in all questions of quality management as well as internal communication of quality and regulation decisions and customer services
• Planning, trust and monitoring internal and external audits as well as analysis of the audit results for trends and consequences of the audit findings

Our client is looking for an individual who is degree educated within a engineering discipline and who has had at least 10 years’ experience working within the quality function of a medical device organisation. You will also need to be able to demonstrate your extensive knowledge of ISO13485, ISO9001 and quality systems regulations,

Due to this role being compliance driven, prior management of internal audit is desirable along with your ability to work across a matrix structured organisation and your successful history of improving compliance across a business,

This is an excellent opportunity to join a global business and impress your mark on the future of the organisation.