Quality Engineer
Due to continued business growth, we are currently recruiting for Quality Engineer based in Limerick. This position will be offered on a permanent contract working full time.
Reporting to the Quality Manager
Duties:
- Manage activities within the project teams ensuring that project planning is completed correctly with full evaluation and engagement from the necessary resources.
- Establish analysis techniques and other quality control tools within project activities as well as utilization of these to solve specific supplier quality problems.
- Champion compliance to applicable Global Regulations and standards (eg. US FDA, 21 CFR 820, ISO and IVDR: In Vitro Diagnostics Regulation)
- Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports
- Collaborate with Quality Manager and team to ensure quality management system is maintained and continually improving
Essential Criteria:
- Third Level qualification in Science, Engineering or a relevant technical discipline. Qualification in Quality/Validation/Statistics/ Risk would be a distinct advantage.
- Proven knowledge and experience (ideally 2- 3 years experience in a similar environment ) of working with ISO13485, ISO14971, the IVD / IVDR: In Vitro Diagnostics Regulation and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11.
- Proven knowledge and experience of all aspects of Validation including Design, Process Validation and Software Validation.
- Good working knowledge of statistics.
- Strong interpersonal skill with the ability to communicate effectively at all organisational levels.
- High attention to detail in all aspects of the role.
- Excellent organisational skills.
- Proven problem-solving skills.
- High self-motivation.
- Good working knowledge of Microsoft Office.
Contact niamh.hoare@eflexes.com or 0858734617
