Role: Senior Quality Engineer (Operations)
Location: Neurent Medical Ltd., Galway
Department: Quality Assurance
Reporting: Quality Manager
DUTIES AND RESPONSIBILITIES:
Support and mentor Quality engineers and technicians. Assign tasks, coordinate and provide instruction and feedback as required.
Champion continuous improvement through CAPA system, analyzing key performance indicators etc.
Lead quality-focused projects ensuring timely completion of project milestones.
Ensure GMP standards and compliance in the assigned area.
Work collaboratively with Operations, Supply Chain and other business functions to ensure quality performance of product and processes.
Participate / lead Risk Analysis initiatives e.g. FMEA.
Review/Approve Validation protocols, reports (IQ, OQ, PQ) and engineering changes.
Develop and maintain documentation in compliance with FDA& ISO requirements.
Collate, trend and report on Quality KPI’s.
Perform internal and external audits to ISO and FDA requirements.
Support Notified Body / Regulatory Agency / Customer Audits.
Support the environmental monitoring process and activities associated with sterilization.
Actively participate in management review, compliance meetings and other key review meetings.
Act as the QA representative on Design Projects supporting new product introductions, qualification of new suppliers, development and approval of new product documentation.
Supplier Management & Qualification: Maintain supplier records and systems, manage Approved Supplier List (ASL) activities, qualify new suppliers through agreements, assessments, audits, and onboarding to the Approved Vendor List (AVL).
Coordinate supplier change requests and qualification plans, monitor supplier performance through scorecards and reviews, and conduct audits to drive corrective actions and ensure compliance.
Undertake additional tasks as directed by the Quality Manager in line with company goals, and act as delegate for Quality Manager when required.
EDUCATION/EXPERIENCE:
Level 8 Degree in Science / Engineering, Quality Engineering or similar qualification.
Minimum 5 years’ experience in a relevant role in the medical device industry.
Clear understanding of medical device quality systems and requirements, including measurement techniques, would be a distinct advantage.
Experience in root cause analytical and problem-solving skills.
Experience of FDA and ISO Quality systems (e.g. ISO13485, FDA QSR 21CFR Part 820) for medical device companies desirable.
Significant test method and process validation experience.
Demonstrated excellent organizational skills and ability to work on own initiative essential.
Excellent written and verbal communication skills.
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