Senior QA/RA Specialist

MCS Group is delighted to be partnering with our medical device client to recruit a Senior QA/RA Specialist based in Ballymena. Due to business growth, this excellent opportunity has become available.

As the Senior QA/RA Specialist you will:

• Manage Notified Body / Regulatory Agency audits
• To carry out and review the results of quality audits which appraise the effectiveness and applicability of the QMS
• Compile materials for license renewals, updates, and registrations
• Maintain product EU technical files
• Post-market surveillance planning and follow-up activities
• Be an integral QA team member in maintaining the company's internal procedures, SOP's and ISO13485:2016 certification

The successful candidate:

• Degree in Engineering / Biological or Other Relevant Science or equivalent work experience
• Relevant experience in a manufacturing QA role obtained in a Medical Device or Invitro Diagnostic Device professional or OTC environment.
• Current working knowledge of ISO 14971, and ISO 13485:2016 as well as European regulations for Medical and In Vitro Diagnostic devices.

To speak in absolute confidence about this opportunity please send an up to date CV via the link provided or contact Kathy Donaghey Senior Specialist Consultant at MCS Group
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