Cure Talent is delighted to partner with a growing Medical Device company based just outside of Glasgow. Due to their continued exceptional growth, we are seeking a QARA Manager to join them.
As the new QARA Manager you will be leading a team of experienced QA & RA professionals, maintaining and developing their QMS, MDR compliance and leading internal & external audits.
The ideal candidate will have a proven background across RA and QA in Medical Devices and a strong understanding of ISO 13485 and MDR (knowledge of GMP is a bonus). You will have experience of managing and developing an ISO 13485 QMS and Batch Release.
Key Responsibilities:
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Management and development of the QMS
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Ensure continued compliance with EUMDR
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Creation and implementation of ISO 13485 compliant SOP’s
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Creation, maintenance and updating of Technical Files
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Support Batch Release of both company own devices and external products
Skills, Experience and Qualifications:
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Proven experience in a Quality Assurance and Regulatory Affairs role in Medical Devices
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Experience of QMS implementation or development
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Experience of Creating, Maintaining or Updating Technical Files
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Proven knowledge and experience of Change Controls, Gap Analysis, CAPA, NCR, Risk Management, PMS, Deviations etc.
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Certified ISO 13485 Internal or Lead Auditor
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Strong knowledge of ISO 13485, ISO 14971, MDD, MDR, FDA, GDP, GMP
If you're looking for an exciting opportunity to be part of a rapidly expanding company at the forefront of health technology innovation, get in touch today