Software Quality Engineer
• 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 organisation corporate non-device software requirements.
• Ensure relevant procedures are kept up to date and maintained to the relevant organisation 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.
Skills, Experience and Qualification:
• Level 8 in Computer Science Engineering / Electronics Engineering/ Biomedical Engineering
• Familiar with Industry standards for medical device SW ( IEC62304) and SW Security Initiatives
• Familiar with C++, C# and embedded C programming languages
• Able to work independently and as part of a team
• Innovative thought process
• Strong presentation skills.
For a confidential discussion and more information on the role, please contact Phil on 021 4911064 or email firstname.lastname@example.org
Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs, our job searching tips & videos!For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie.
For more information on Collins McNicholas, contact one of our six branches across Ireland in Dublin, Cork, Galway, Sligo, Athlone, Limerick.