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 Bachelors degree in Engineering, Life Sciences, or related technical field.
58+ 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.