My leading MedTech client in the oncology space is looking for a Quality Engineer II. They have recently secured a large amount of funding from the US, and are rapidly expanding their branch in Galway. This is a great opportunity to join a company with an amazing patient-centric mission (to improve the lives of cancer patients) in a high impact role; ensuring quality, compliance, efficiency, and scalability.
Experience Requirements – The Ideal Candidate Must Have:
- Level 8 degree or equivalent in relevant discipline (e.g. Engineering/Science /STEM/ASQ CQE).- Minimum of 2 years relevant engineering experience within an ISO certified medical device company.- Strong understanding of ISO 13485 standard, FDA Part 21 CFR 820 and other medical device regulation.- Excellent problem-solving and root cause investigation skills.- Proficient in using quality management systems (QMS) and MS Office Suite.- Good documentation skills and attention to detail.- Strong communication and organisational skills.- Proactive approach to problem-solving.- Ability to work independently with minimal supervision and cross functionally.- Confident communicating with internal and external stakeholders.
If you're interested please submit your CV.