Validation Team Lead
Full Time
Kilkenny
Kilkenny
Diabetes Care Kilkenny
The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.
The Role
To support the development and onward growth of Client's Kilkenny site, we have an exciting opportunity for a Software Quality Engineer to join the team. In this role you can grow your career as you help the team shape the future of healthcare.
The facility will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies, including the FreeStyle Libre 3, a system that automatically delivers real-time, up-to-the-minute glucose readings, with the smallest and thinnest wearable glucose sensor that provides unsurpassed 14-day accuracy and optional glucose alarms directly to smartphones. This enables people with diabetes to live the best and fullest lives they can.
The Role
To support the development and onward growth of Client's Kilkenny site, we have an exciting opportunity for a Software Quality Engineer to join the team. In this role you can grow your career as you help the team shape the future of healthcare.
- 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..
- 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.
- 3rd Level Degree in an Engineering, Computer Systems or Science discipline.
- A minimum of 2 years experience in full Software Lifecyle activities / SDLC, CAPA systems, ALCOA Principles, and 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
