Quality Engineer II – MedTech, Galway Impact & Compliance

Women Building Bio

Galway

On-site

EUR 55,000 - 75,000

Full time

6 hours ago

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Job summary

Women Building Bio in Galway is seeking a Quality Engineer II to strengthen the quality function in a fast-growing MedTech oncology-focused team. You will ensure compliance with ISO 13485 and relevant medical device regulations, drive root cause investigations, and support cross-functional colleagues to improve process efficiency and product quality in a patient-centric mission.

The ideal candidate has a Level 8 degree and at least 2 years of medical device quality engineering experience, with

Qualifications

Level 8 degree or equivalent in relevant discipline (Engineering/Science/STEM).
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.