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Senior Manager Global Quality Systems

Job Description

We are currently working with a global medical device organisation that due to progression is currently looking to recruit an experienced quality assurance professional to join their corporate team.

The role will be Responsible for:


  • The QM-Systems of our clients Device Division including conception, design and implementation of harmonized processes for Quality Assurance and Quality Management
  • Responsible for being the divisional Key Contact for Corporate Notified Body regarding ISO 13485 and MDD certification including creation of divisional change notifications.
  • Responsible for audit planning
  • Global Internal Audits according to ISO 9001, ISO 13485, MDD and 21 CFR 820 of FK organizations whilst ensuring that quality requirements are implemented and being followed, and approve corrective action plans and approaches.


Whilst these are the core components of the position there will be various other responsibilities held by this role.


To be considered for this position candidates will need to possess at least 7 years quality management experience, be degree educated with strong working knowledge of Notified Bodies and CE Marking of Medical Devices.


Although a particular product knowledge is not essential you will need to have experience working within the Medical Device sector, have a very good understanding of ISO13485, MDD and 21 CFR 820.


Due to the nature of this position an understanding or an appreciation of working within a matrix structured organisation is needed and the ability to effectively commute and drive change within a cross cultural environment would be preferred.


This is an excellent opportunity to join a progressive and dynamic business which can offer you a long and advancing career.