PEGlobal are looking for a CSV Quality Engineer for our multinational medical devices client based in Scotland.
Main responsibilities of the role;

  • To coordinate projects associated with the validation of computer systems [IT, Control and End user] as directed
  • To organize and lead Validation working parties associated with computer systems, providing a timely validation coordination service to Project Managers or identified Project Leaders
  • To offer support and input to quality manager/CSV lead to work towards a common computer systems validation process
  • To deliver information on current regulatory and company standards that must be met to achieve and maintain compliance
  • To prepare and issue Validation Master Plans, Protocols, Summary Reports and other documentation associated with validation of computer systems, as appropriate for each validation exercise
  • To guarantee all validation activities and documents are authorised and appropriate compliance approval is gained
  • To confirm that all validation activities are carried out and reported in a timely manner
  • To  guarantee compliance through assisting in audits
  • Through effective communication and training initiatives develop staffwithin projects and validation teams to ensure that validation projects are carried out in accordance with the companies Policies and Procedures
  • To facilitate, encourage and coordinate continuous improvement with respect to validation activities within the team
  • Keep management informed of significant quality issues in a manner commensurate with the potential impact of the issue on public health, employee health & safety, company operations, and/or the environment
Required Skills / Knowledge of the successful candidate:
  • Previous experience working in a regulated industry carrying out computer systems validation and/or testing activities
  • Minimum of two years working in an FDA regulated environment carrying out computer systems validation and/or testing activities
  • Knowledge of bespoke computer software and/or hardware specification, testing and documentation
  • Knowledge of the specification, testing and implementation of automated equipment with integrated and networked software applications
  • Experience in in the validation of the following (SCADA, PLC, Vision systems, Firmware, MES, Database and bespoke applications)
  • Software risk assessment and risk based testing methods
  • Experience in document authoring of validation deliverables.
  • In depth knowledge of 21 CFR 820, 21 CFR part11, ISO 13485:2003 and European regulations associated with the medical device industry
  • In depth knowledge of GAMP 5 and SDLC process methodologies.