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 email@example.com
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