Our customer is a Dublin-based global pharmaceutical company committed to setting new standards in healthcare. Working around the world to provide 7 billion people access to high-quality medicine, innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership.
- Responsibility for comparator product activities within our companies Global Device Development, including building and maintenance of the physical and electronic library and comparator testing.
- Performs mechanical and functional testing on medical devices and combination products using standard and bespoke techniques developed to meet requirements of device testing strategy.
- Develop Design Verification test plans in line with ISO 11608 and ISO 11040 and other relevant regulatory guidelines. Participate in design reviews throughout the device product lifecycle by identifying and addressing any analytical gaps and providing technical expertise to the project lead. Ensure all technical issues encountered are discussed with the relevant SMEs within the design and development group.
- Review and interpretation of analytical data in line with study and protocol objectives. Compilation of technical reports to support design and development lifecycle.
- Represent the device and product performance group on cross functional teams both internally within GDD to support design control on a range of device programs.
- Work with external laboratories to ensure study protocols are executed in line with GDD requirements including quality and regulatory requirements.
- Performing method validation and verification activities to support product testing.
- Performing device investigations and participate in GDD and technical investigation teams as required.
- Reporting and logging of aberrant results using Trackwise?. Troubleshoot instrumentation and investigate aberrant sample results.
- Maintaining a high standard of GMP in line with the GDD QMS ensuring audit readiness at all times.
- Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks.
- Degree in Science/Engineering in addition to relevant work experience in the medical device or pharmaceutical industry.
- Previous experience of testing and working with medical devices and/or combination products i.e. Pre-filled Syringes or pen injectors is desirable.
- Previous experience in laboratory equipment qualification and analytical method verification and validation is desirable.
- Understanding of Design Control requirements and working within a GMP controlled regulatory environment. A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
- Highly driven and motivated person who has the ability to work as part of a flexible, dynamic team whilst taking responsibility for individual tasks.
- Some travel will be required as part of this role.
For further information on this position please contact Gavin Kennedy at The RFT Group on 01 2302400 / firstname.lastname@example.org. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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