Role
ROLE:
Senior Quality Engineer (Operations)
LOCATION:
Galway
DEPARTMENT:
Quality Assurance
REPORTING TO:
Quality Manager
Overview
Seeking a dedicated and detail-oriented Senior Quality Engineer to join an Operations team.
The successful candidate will ensure the quality and compliance of manufacturing processes, contributing to the delivery of high-quality medical devices.
Responsibilities
Mentor and support Quality engineers and technicians, assigning tasks and providing guidance and feedback.
Drive continuous improvement through CAPA systems, KPI analysis, and quality-focused initiatives.
Lead quality projects, ensuring timely completion of milestones.
Ensure GMP compliance in assigned areas and collaborate with Operations, Supply Chain, and other teams to maintain product and process quality.
Participate in and lead Risk Analysis initiatives (e.g., FMEA).
Review and approve validation protocols and reports (IQ, OQ, PQ) and engineering changes.
Maintain documentation in compliance with FDA and ISO requirements.
Collate, trend, and report on Quality KPIs.
Conduct internal and external audits to ISO and FDA standards, supporting regulatory and customer audits.
Support environmental monitoring and sterilization activities.
Act as QA representative on design projects, new product introductions, supplier qualifications, and product documentation approvals.
Manage supplier relationships and qualification processes, including audits, performance monitoring, and corrective actions.
Undertake additional tasks as directed by the Quality Manager and act as delegate when required.
Education & Experience
Level 8 Degree in Science, Engineering, Quality Engineering, or a related field.
Minimum 5 years' relevant experience in the medical device industry.
Strong understanding of medical device quality systems and measurement techniques.
Experience with CAPA and root cause analysis.
Knowledge of FDA and ISO Quality systems (e.g., ISO *****, FDA QSR 21CFR Part 820) desirable.
Experience with test method and process validation.
Excellent organizational, written, and verbal communication skills.
People management experience desirable but not essential.
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