Senior Quality Assurance Specialist

1 day ago


Cardiff, Cardiff, United Kingdom Linea Resourcing - STEM Recruiter Full time
Quality Assurance Role

At Linea Resourcing, we are seeking a skilled Senior Quality Assurance Specialist to join our team. This exciting opportunity will enable you to contribute to the overall business performance and quality of products.

The ideal candidate will have previous experience managing QMS systems in a medical device or pharmaceutical setting, including CAPA, NCRs, ECNs, ECRs, and detailed knowledge of ISO 13485, MDD, and FDA regulations.

In this role, you will be responsible for managing CAPA activities and associated reporting, conducting and supporting internal and external audits, managing QMS and relevant quality documentation, advising engineering, production, and design teams on regulatory requirements and standards, providing internal guidance and training on QMS documentation and processes, and developing new and improving existing QMS documentation and processes.

Key qualifications include:

  • Previous experience managing QMS systems in a medical device or pharmaceutical setting
  • Detailed knowledge of ISO 13485, MDD, and FDA regulations
  • Experience performing internal audits and hosting external audits

The successful candidate will receive a competitive salary of £38,000 + 10% bonus + benefits.



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