Quality Assurance Specialist

2 days ago


Cardiff, Cardiff, United Kingdom Linea Resourcing Ltd Full time
Company Overview
Linea Resourcing Ltd is a technology development and manufacturing business offering hybrid working. Our company prioritizes the overall business performance, compliance, and quality of products.

Job Summary
We are seeking an experienced Quality Systems Engineer to join our team. As Quality Systems Engineer, you will contribute to the overall business performance, compliance, and quality of products. The role offers a competitive salary, bonus, and extensive benefits.

Key Responsibilities:
  • Manage CAPA activities and associated reporting.
  • Conduct and support internal and external audits.
  • Manage QMS and relevant quality documentation.
  • Advise engineering, production, and design teams on relevant regulatory requirements and standards.
  • Provide internal guidance and training relating to QMS documentation and processes.
  • Develop new and improve existing QMS documentation and processes.

Requirements:
  • Previous experience managing QMS systems in a medical device or pharmaceutical setting including CAPA, NCRs, ECNs, ECRs, etc.
  • Ideal knowledge of ISO 13485, MDD, and FDA regulations.
  • Experience performing internal audits and hosting external audits.
  • Excellent report writing and communication skills.

Benefits and Salary
This role comes with a competitive salary of £38,000 + 10% Bonus + Benefits. Join our team and take advantage of our hybrid working policy.

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