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Quality Assurance Specialist

2 months ago

Castle Donington, Leicestershire, United Kingdom Medstrom Full time

Job Summary:

We are seeking a highly skilled Quality Technician to join our team at Medstrom. As a Quality Technician, you will play a critical role in ensuring the implementation and maintenance of our ISO13485 Quality Management System (QMS).

Key Responsibilities:

  • Support the development, review, and revision of quality system documentation, including procedures, work instructions, and forms.
  • Manage and maintain quality records, ensuring accuracy, completeness, and accessibility.
  • Conduct internal audits to identify and address potential non-conformances in the QMS.
  • Support preparation for external audits by regulatory bodies.
  • Analyse quality data and participate in corrective and preventive action (CAPA) activities.
  • Stay up-to-date on regulatory requirements for medical devices, including ISO13485 and relevant regional regulations.
  • Contribute to continuous improvement initiatives within the QMS.

Additional Responsibilities:

  • 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, including Excel and Word.
  • Experience working within a QMS environment, ideally in the medical device industry.
  • The ability to work in a fast-paced environment with strict deadlines.
  • The ability to generate detailed, high-quality documentation.
  • The ability to perform and/or manage multiple tasks in parallel.
  • Excellent interpersonal skills with the ability to collaborate with others.
  • To be detail-orientated and strive for continuous improvement.

About Medstrom:

Medstrom is a growing company that has expanded extensively within the last 5 years. We offer great career opportunities for those who are keen to progress.

Working Hours:

Standard working hours are 37.5 per week, Monday to Friday, approx. 8.30am – 5pm, with flexible hybrid working available once trained.