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Quality Coordinator - ISO 13485

Surrey   •  £30000 - £35000 per annum  •  Permanent, Full time

A growing medical device company has an opportunity for a Quality Coordinator to join its team. You will support across a range of quality tasks and functions including maintaining and managing CAPA, change controls and audits. You must have experience of working in the medical device industry or to ISO 13485, ideally in a quality related role.

Key Duties & Responsibilities:

  • Commitment to continuous Quality Improvement
  • To be fully compliant with FMD's Medical Device (MD) SOPs and Pharma SOPs relevant to role
  • Coordinating role for the quality function including producing minutes and actions for monthly quality meetings
  • Working with the Head of Quality and Quality Manager to ensure procedures and systems are maintained or established to maintain the Company's compliance with ISO 13485 and to enable the manufacture of medical devices in accordance with current national and international legislation, relevant regulations, standards and guidelines
  • Supporting the Quality Manager with the ongoing contribution to the maintenance and development of Business Operating Procedures
  • Responsible for co-ordinating periodic training and familiarisation processes in accordance with the MD Training and Familiarisation Matrix
  • Providing support for inspections by regulatory bodies; notified bodies; customers; and independent associates
  • Scheduling and coordinating Management Review Meetings; preparing necessary information required; and ensuring review outputs are recorded and available
  • Supporting the implementation of External Audit and Internal Audit Plans
  • Coordinating, tracking and documenting MD Supplier Assessments and Reassessments
  • Responsible for maintaining the Change Control Register, tracking actions to completion, providing regular updates regarding CC completion to the Head of Quality and Quality Manager and retaining the completed Change Control Forms
  • Responsible for maintaining the CAPA Register, tracking actions to completion, providing regular updates regarding CAPA completion to the Head of Quality and Quality Manager and retaining the completed CAPA Forms
  • Responsible for processing MD customer complaints
  • Supporting the translation process for commercial product pack copy where FMD is the legal manufacturer
  • Supporting the collation of feedback data from production and post-production activities, including the implementation of the MD Post Market Surveillance Plan, and its retrospective review by the Management Review process
  • Arranging training and guidance to relevant staff within the Company as appropriate
  • Responsible for Document and Record Management including maintaining MD QMS reference files; quality records; records of suppliers; audit reports; and documents of external origin
  • Arranging and participating in regular Distributor meetings (where relevant), ensuring outputs are recorded and available and tracking actions to completion
  • Supporting and/or coordinating ad hoc projects as required

Knowledge, Competencies and Experience Required:

  • Degree educated
  • Previous experience working in the medical device industry
  • Good knowledge and experience of Quality Management Systems, e.g. ISO 13485, ISO 9001, GCP, GMP, GDP and the EU and UK Medical Devices Regulations
  • Successful experience of being inspected by MHRA/Notified bodies
  • Excellent written and verbal communication skills
  • Good project management skills and capability to work with a small team of people
  • Demonstrable attention to detail
  • Good team player, but also able to show initiative and be self-sufficient within a small company structure
  • Ability to establish priorities and meet deadlines
  • Strong work ethic, enthusiastic and self -motivated
  • Excellent computer skills, including strong working knowledge of Microsoft Office (Word, Excel, Power Point and Outlook)

You must have the right to work in the UK. Learn more

  • Agency: Cranleigh Scientific
  • Reference: 7096
  • Posted: 12th October 2021
  • Expires: 9th November 2021

Cranleigh Scientific

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