ROLE OVERVIEW:

The purpose of this position is to maintain, improve and facilitate the efficient running of the Quality Management System (QMS), and to assist in the execution of the day to day operational activities of the QA department and to support the Quality Assurance Manager.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Co-ordinate and conduct both internal and supplier auditing
  • Initiating and coordinating non-conformance reports and/or CAPAs to closure
  • Working with other departments and suppliers to ensure timely processing of SCARs
  • Processing customer complaints, facilitating subsequent corrective and/or preventative actions
  • Maintain the QARA logs and following up on the completion of actions where required
    • Maintaining control of the measuring and monitoring devices used in the manufacture and service of products, both in-house and by approved suppliers.
    • Maintain an effective approved supplier system
    • Check compliance of test results to QMS standards
    • Monitor and advise on the performance of the QMS, produce data measuring against KPI’s
    • Ensuring QMS is maintained in accordance with ISO9001/13485
    • Manage and update policies and procedures within the current QMS
    • Ensuring all staff are adequately trained in quality processes and SOP’s
    • Advising on improvements to processes
    • Any other quality related duties as defined by the Quality Assurance Manager not listed above

KNOWLEDGE AND SKILLS REQUIRED:

  • 3-5 years’ experience in a quality or compliance function, with an in- depth knowledge of ISO 13485
  • Able to demonstrate auditing experience, both internal and external
  • An excellent standard of written and spoken English
  • A desire to progress and take on further responsibilities
  • An aptitude to analyse data
  • Problem solving skills
  • To be able to work with a team and be persuasive

OTHER REQUIREMENTS:

  • Self-starter
  • All round proficiency in communication
  • Organisational skills
  • Presentation skills
  • Results driven
  • Strategic thinking