ROLE: Senior Quality Engineer (Operations)
LOCATION: Galway
DEPARTMENT: Quality Assurance
REPORTING TO: Quality Manager

ROLE 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.

KEY 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 13485, 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.