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Quality Manager

Quality Manager

Job description

Quality Manager

About Your New Employer

In your job as Quality Manager, you will be working for a growing Medical Device company in Galway. In your new job you will be working towards saving people's lives.

About Your New Job

  • You will provide guidance to project teams and engineers in developing protocols, reports, procedures, deviations and change requests for identified projects
  • It's your job to provide technical support for the manufacture of existing products and the growth and development / transfer of new products / technologies.
  • As Quality Manager you ensure the QMS including document control system, calibration system, internal audits and NCR/CAPA system is maintained.
  • You will monitor the suitability and effectiveness of the QMS and assure compliance with current US and international regulations and ISO standards.
  • You will participate in specification development in relation to design input development
  • It's your job to manage and oversee key elements of Batch Release
  • You will manage supplier approval and qualification of new/revised items including supplier audit & Non-Conformance.

What You Need

  • A Bachelor (level 8) of Engineering, Sciences or equivalent experience, minimum of 8 years experience in a healthcare environment.
  • 5 years experience within Medical Device, Pharma industries
  • Experience and understanding of regulations related to medical devices e.g. ISO 13485, MDD, MDR and applicable FDA Requirements
  • Experience in conducting audits in a regulated environment 

What's on Offer

In addition to all statutory entitlements and a meaningful job where you help save lives, you will get:

  • Annual Bonus
  • Fully covered Health Insurance 
  • Pension Scheme
  • Stock Ownership Programme
  • Flexitime

What’s Next

Apply for your new job now by clicking the apply button, or contact Dean Flynn at Sigmar Recruitment for more information T: +353 91 455306 E: dflynn@sigmar.ie

All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent

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