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QA Batch Release Specialist

Birmingham   •  £25,000 - 30,000  •  Permanent, Full time


Quality Assurance Specialist
Birmingham, West Midlands
Industry: Medical Devices
Salary: 30K
Full time / Office based
Excellent Benefits

This globally recognised organisation specialises in the development, manufacture and distribution of Medical Diagnostic products. Due to recent rapid growth they now have an exciting opportunity for a Quality Assurance Batch Release Specialist to join their skilled Medical Devices team based in Birmingham, West Midlands.

Responsibilities
Reviewing completed Device History Records (DHRs) to ensure that all standards and regulatory requirements have been met for product release
Supporting the wider QA department in ensuring the quality management system meets all requirements of relevant regulatory standards and standards (ISO 13485, FDA CFR 820 part 21, QSRs)
Line management of the QA Batch Release team within the Quality Administration Group, including ensuring all members are properly trained for their duties
Establishing appropriate timelines for long term projects
Coordinating workload and setting objectives for direct reports to ensure that operative objectives are met and delivered within agreed timescales
Coordinating staff 1-2-1s, IPDs, development plans and addressing any performance issues for direct reports
Carrying out Device History Record checks at predetermined manufacturing gateways to enable product release
Continually working towards making improvements in the release process

Successful candidates will have the followings skills & experience:
Experience of working within a Quality Assurance position
Experience of working with Medical Devices to ISO 13485 standards
Management or supervisory experience
Excellent understanding of Quality principals / Quality Systems

Please note in order for your application to be successful you must hold a valid right to work document for the UK as no sponsorship is offered.

To apply for this role please send your CV through to Kully Sahota, Senior Consultant, Kully.sahota@medtechprofessionals.com or call 07557 047 380 for more information

  • Agency: Clinical Professionals
  • Contact: Kuljita Sahota
  • Reference: JO-1901-422231
  • Posted: 9th January 2019
  • Expires: 6th February 2019

Clinical Professionals

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