Quality Assurance Specialist

3 days ago


Castle Donington, Leicestershire, United Kingdom Medstrom Full time

Your Role:

As a Quality Technician at Medstrom, you will be responsible for ensuring the implementation and maintenance of the ISO13485 Quality Management System (QMS). This involves:

Key Responsibilities:

  • Supporting the development, review, and revision of quality system documentation
  • Managing and maintaining quality records
  • Conducting internal audits to identify potential non-conformances
  • Supporting preparation for external audits by regulatory bodies
  • Analysing quality data and participating in corrective and preventive action activities

Additionally, you will:

  • Manage complaint investigations
  • Coordinate supplier audits
  • Support risk management activities
  • Monitor quality data for each site
  • Review Device History Records (DHRs)
  • Facilitate non-conformance audits

Requirements:

  • A strong level of IT literacy with experience of common desktop applications
  • Experience working within a QMS environment, ideally in the medical device industry
  • The ability to work in a fast-paced environment with strict deadlines
  • Excellent interpersonal skills with the ability to collaborate with others
  • To be detail-orientated and strive for continuous improvement

Medstrom offers a dynamic and supportive work environment, with opportunities for growth and development. If you are a motivated and organized individual with a passion for quality and regulatory compliance, we encourage you to apply for this exciting opportunity.



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