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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
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
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.
Good working knowledge of Microsoft Office.
Contact email@example.com or 0858734617