Software Quality Lead

JO-2312-527098 Software Quality Lead required for medical device manufacturing facility in Kilkenny. Will lead a small specialist team on-site. Exciting opportunity to join this greenfield manufacturing site and grow your career with a global leader in its field. Role

• Lead the team responsible for the validation and verification of computerised systems
• Assist in the development & implementation of software systems & policy compliance to regulatory requirements including, FDA QSRs, ISO13485 & IVDD.
• CSV subject matter expert to ensure compliance with GMP, and Data Integrity requirements on all systems.
• Collaborate and support digital and data analytics projects.
• Communicate clearly to stakeholders regarding active risk management and problem solving
• Champion training and development of team.
• Ensure validation and qualification activities of processes, methods, and equipment comply with internal requirements and applicable regulations and standards.
• Experience, and understanding of Software Change Control
• Analyse quality and process data using statistical techniques to identify trends and implement improvement plans accordingly.
• Develop key metrics/indicators to track performance and compliance and analyse data to develop and implement improvements .
• Analyse and implement corrective action in relation to non-conformance

• 3rd Level Degree in an Engineering, Computer Systems or Science discipline.
• Min 5 years experience in full Software Lifecyle activities / SDLC, CAPA systems, ALCOA Principles
• Experience leading on quality software projects ideally in Medical Device or Pharmaceutical manufacturing
• Proficient Microsoft office suite
• Strong problem solving and analysis skills
• Proven presentation experience