Senior Quality Engineer (Operations & Compliance Lead)
Join an innovative, growing Medical Device company based in Galway, focused on pioneering solutions that are changing patient lives in the healthcare sector. We operate a proactive Quality Assurance department that is integral to our Operations team and drives compliance and continuous improvement throughout our manufacturing and supplier are seeking a proactive and detail-oriented Senior Quality Engineer to act as a technical and quality champion for our Operations team. This role is a key leadership position focused on managing and improving the QMS, leading complex quality projects, and ensuring robust supplier qualification. If you have a passion for driving systemic improvement and want a pathway to management responsibility, this is the ideal next step.
Key Responsibilities
Continuous Improvement & CAPA: Champion continuous improvement initiatives, driving the CAPA system and analyzing key Quality KPI's to reduce variation and improve performance.
Quality Leadership: Support and mentor junior Quality Engineers and Technicians, assigning tasks, coordinating workload, and providing technical instruction and feedback.
Validation & Documentation: Review and approve crucial documentation, including Validation protocols and reports (IQ, OQ, PQ), and engineering changes.
Audits & Compliance: Lead and participate in internal and external audits to ISO 13485 and FDA requirements, and support Notified Body and Regulatory Agency inspections.
Supplier Qualification: Lead Supplier Management and Qualification activities, including maintaining the Approved Supplier List (ASL), qualifying new vendors through audits and assessments, and monitoring supplier performance via scorecards.
Cross-Functional Support: Act as the Quality Assurance representative on Design Projects supporting new product introductions, and ensure GMP standards are upheld across all areas (Operations and Supply Chain).
Risk Management: Actively participate in and/or lead Risk Analysis initiatives (e.g., FMEA) and root cause analysis investigations.
Candidate Profile
Education: Level 8 Degree (or equivalent) in Science, Engineering, Quality Engineering, or a similar technical field.
Experience: Minimum 5 years’ relevant experience within the Medical Device industry is essential.
QMS & Regulatory: Clear understanding and practical experience with FDA QSR (21CFR Part 820) and ISO 13485 Quality Systems.
Core Technical Skills: Significant experience with test method and process validation activities is a must.
Problem Solving: Proven experience in root cause analysis and CAPA methodologies.
Organizational: Excellent organizational skills and the ability to work effectively on own initiative are essential.
Advantageous: Experience in people management or demonstrated mentorship experience is highly desirable.
Interested in leading high-impact Quality projects in Galway? Apply in confidence today or contact James Cassidy for more details.
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