Job Title:Quality Control Co-ordinator

Primary Role:

  • Work with the Quality Team to ensure that QC system requirements are effectively established and maintained
  • To develop and manage Sphere’s in-house Quality Control activities;
  • To develop the protocols employed to assess the quality and performance of incoming raw materials, intermediates and products as required.
  • To ensure that only suitable material is released for subsequent manufacture and or sale, including release onto company ERP system


  • To ensure that outgoing product meets specifications.
  • To collaborate with other company members on Quality Control issues
  • To co-ordinate the validation of Quality Control methodology and related software.

Other Roles:

  • To finalise current test RD procedures and practices into the Quality System in compliance with ISO 13485 or other required standards.
  • Co-ordinate the preparation and/or maintenance of computer programs for the compiling and analysis of QC data
  • Co-ordinate the development, maintenance and review of QC charts
  • Co-ordinate and track QC activities associated with the CAPA process, providing a QC resource for problem identification, resolution and continuous improvement
  • Co-ordinate the development and presentation of the training program for QC related activities, developing training protocols and documentation requirements
  • Assist in supporting onsite QMS, Notified body and customer audits
  • Provide reports on QC activities as required
  • Assist with other relevant activities or projects, as required
  • To liaise with QA on quality issues;
  • To contribute to product specifications;
  • To contribute to performance and reliability protocols


  • Excellent numeric skills (proficient with Excel)
  • High level of computer skills (Word, PowerPoint)
  • Good communication skills
  • Keen attention to detail and proven ability to perform experiments in an efficient and safe manner.
  • Ability to develop and follow procedures in a repeatable manner and to a high standard.
  • Ability to organise own work and that of others to meet deadlines.

Personal Attributes:

  • Highly self motivated
  • Well organised and detail-oriented
  • Team-player, ability to work effectively within a multi-disciplinary team;
  • Ability to motivate others;
  • Self confident;
  • Attention to detail;
  • Open and honest;
  • Able to work to tight deadlines.


  • Science or Engineering degree or HND


  • Aminimum of Fouryears’ experience in a similar role, preferably within the medical device / pharmaceutical industry
  • Experience of working within quality systems essential e.g. ISO 9001, 13485,GLP, GMP
  • Experience of supporting ISO 13485 and FDA audits preferred but not essential.
  • Experience as internal auditor preferred.
  • Working with cross functional groups

FM:113 Issue 3 17/10/2014 Page 1 of1