Quality Engineer

Job Ref.No: 
13882
Publish Date: 
20/01/2022 - 00:00 to 19/02/2022 - 00:00
Location: 
Classification: 
Contract Type: 
Permanent Full Time
Salary Min: 
0
Salary Max: 
0

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