Senior Software QA

Contract
Remote (Ireland based)
Senior Software Quality Assurance
Ireland - Remote

The Senior Software Quality Assurance role is required to ensure that compliance to the site, corporate and regulatory body equipment & automated system and software validation requirements.

Key Responsibilities 
  • Subject Matter Expert on equipment & automated systems validation.
  • Strong working knowledge on Software Validation 
  • Responsible for the review and approval of all documentation through the equipment and automated systems lifecycle. 
  • Ensure regulatory compliance with internal and external validation regulations, particularly with corporate non-device software requirements.
  • Ensure relevant procedures are kept up to date and maintained to the relevant 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.
  • Present relevant documentation during internal and external audits.
Education & Experience
  • Bachelors’ degree in relevant STEM discipline with 5+ years experience in ideally a medical device or highly regulated manufacturing environment
  • Demonstrated experience planning and executing testing of complex applications
  • Demonstrated success working in a highly collaborative, matrix environment, with a track record of accomplishments with measurable business impact
  • Strong sense of personal accountability and courage to change how we work
  • Proven aptitude to learn quickly and improve processes
  • Strong verbal and written communication skills and the ability to collaborate effectively with team members and business partners
  • Ability to negotiate, influence, and collaborate to build successful relationships