Quality Engineer II

Women Building Bio; Galway; On-site; EUR 55,000 - 75,000; Full time

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.

Skills

Root cause analysis

Quality management systems (QMS)

MS Office

Documentation skills

Stakeholder communication

Cross-functional collaboration

Independent work

Regulatory knowledge

Process improvement

Education

Bachelor's degree in Engineering/Science

Tools

QMS software

Job description

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.