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Software QA Manager

A permanent opportunity has arisen with a global medical device client who are looking to hire a Software Quality Assurance Manager to join their team on a permanent basis as they continue to expand.


This position will be responsible for managing Software Quality leads and the development, deployment and maintenance of Software Quality and Validation policies, procedures, and methods in accordance with internal and external regulatory requirements. 



  • Develops and manages a high-performance Software Quality engineering team with focus on customer needs, compliance, product quality, and risk mitigation.
  • Demonstrate mastery of the software validation processes such as GSM, Spreadsheet Validation.
  • Must possess a fundamental understanding of quality philosophies, principles, methods, tools, standards, and regulatory requirements.
  • Takes a leadership role in developing and implementing initiatives to enhance the Quality management system.
  • Develop staff on new quality initiatives and assists understanding and rollout of quality initiatives.
  • Champion continuous improvement with particular focus on Computer System Validation initiatives.
  • Acts as lead project team member who provides independent review on validation deliverables used to develop, implement, and maintain IT/clinical/manufacturing/Quality software.
  • Responsible for the full definition and capability of a software system and for developing new methods and processes from strategy to execution.
  • Proactively investigates, identifies, and implements best-in-class Software Quality Engineering practices.
  • Proactively identifies industry best-practices and leads efforts to develop, improve, and simplify quality system practices.
  • Contributes to the development, review and / or approval of SOPs and supporting Work Instructions.
  • Establishes and supports global and classroom training curriculum and provides project direction, coaching and mentoring for the application teams.


 Qualifications and Experience:

  • Level 8 Bachelor’s level degree in Science/Engineering/Software discipline.
  • 9+ years of related experience, including 5+ years of experience in Software Quality Assurance and validation and 2+ years of experience in People Management.
  • Working knowledge of regional and international quality system requirements including 21 CFR 820, ISO 13485, CFR Part 11, and SoX for Medical Devices
  • Experience in working with ‘Agile’ software development and validation methodologies
  • Experience managing projects and project deliverables to completion

For a more detailed job spec and confidential discussion on this role contact Amy Newell.