Software Quality Engineer

Job Title: Software Quality Engineer
Contract Type: Permanent
REF: 123359
Contact Name: Gavin Kennedy
Contact Email:
Job Published: over 3 years ago

Job Description

Key Responsibilities:

  • Site Subject Matter Expert (SME) person and co-ordinator for computer validation/test activities.
  • Site SME for software validation during internal and external audits.
  • Ensure regulatory compliance with internal and external validation regulations, particularly with our client's corporate non-device software requirements.
  • Ensure relevant procedures are kept up to date and maintained to the relevant company standards and to industry best practice.
  • Provide guidance and assistance with the preparation of validation protocols, test protocols, software design specifications, and associated documentation for all applications supporting the quality system and equipment and automated systems.
  • Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for System designs.
  • Provides guidance, training and direction the non-device software lifecycles to staff across various functions. Provide software validation/compliance/part 11 leadership.
  • Take part in vendor audits of critical equipment vendors.