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Job Description

We are currently working with a dynamic, innovative and growing medical device organisation that has aggressive plans to expand their organisation globally.

Specialising within the electromechanical space this position will have a key role in the implementation of the organisation overall business strategy by establishing and leading major QMS related projects whilst working to a leader for compliance and continuous quality improvements.

The position will lead a small team which will coordinate cross functional activities including R&D, production, Technical Services, Warehousing and Sales.

Some of the most critical responsibilities include;

  • Identify regulatory and quality gap and design & implementing improvement plans
  • Review and improve critical processes like document control, change management and design control
  • Support Design process and assure compliance (according to MDD & FDA) for heavy ongoing development plans

To be considered for this role candidates must come from a technical background and have strong technical quality experience and have prior working knowledge of Electromechanical medical device products. You will need excellent knowledge of 21 CFR 820 and ISO13485 strong design quality exposure and have experience support manufacturing operations.

This is an excellent opportunity to join and progressive business where the role will play an important part in the success development and growth of the business. Individuals will need to be able to demonstrate excellent communication and interpersonal skills and the ability to drive indirect teams within a complex environment.

The client is open to supporting relocation, there will be some travel involved with the position.  

 
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