Senior Quality Engineer
Location: Galway, Ireland (Hybrid)
Department: Operations
Type: Full-time, Permanent
Role Overview
The Senior Quality Engineer will lead operations quality activities to support the commercialisation and manufacturing scale-up of a new electro-mechanical medical device. The role ensures full compliance with regulatory standards while working closely with a contract manufacturing partner to establish, validate, and maintain robust production and quality processes.
Key Responsibilities
* Ensure compliance with FDA QSR 21 CFR 820, ISO 13485, ISO 14971, EU MDR, and other applicable regulations.
* Lead operations quality engineering for new product introduction, including risk management, verification & validation, process controls, CAPA, documentation, and production ramp.
* Develop and maintain process validation (IQ/OQ/PQ), equipment qualification, and test method validation, in collaboration with contract manufacturers.
* Drive root cause analysis, CAPA, non-conformance investigations, and quality trending.
* Support supplier quality activities including audits, qualification, and performance monitoring.
* Participate in internal/external audits (FDA, NB, ISO, MDSAP).
* Develop quality metrics, support management reviews, and lead continuous improvement initiatives.
* Collaborate with cross-functional teams (R&D, Manufacturing, Supplier Quality, RA/QA) with a strong compliance-focused mindset.
* Create and maintain quality procedures, work instructions, and specifications.
Required Qualifications & Skills
* Bachelor's degree in Engineering, Life Sciences, or related technical field.
* 5–8+ years' experience in medical device quality engineering, including:
* Electro-mechanical medical devices or similar regulated technology.
* Contract manufacturing (CMO) oversight and supplier quality experience.
* Hands-on design controls, risk management, process validation, production controls, and CAPA.
* Strong knowledge of FDA QSR, ISO 13485, ISO 14971, and EU MDR.
* Proficiency in statistical tools (Minitab or equivalent) and quality tools (FMEA, SPC, DOE, RCA).
* Strong analytical, problem-solving, and communication skills with a "quality-first" mindset.