An exciting opportunity is available for an experienced Quality professional to join a leading global medical device manufacturing environment. The role focuses on driving Corrective and Preventive Action (CAPA) activities, supporting Quality Management System (QMS) effectiveness, and ensuring compliance with regulatory and quality standards.
Purpose
Facilitate and execute the CAPA process, support continuous improvement of the QMS, and apply risk-based decision-making to ensure compliance, product quality, and operational effectiveness.
Key Responsibilities
- Lead or support CAPA investigations and projects, ensuring compliant and timely closure.
- Perform root cause analysis and problem-solving using quality methodologies.
- Investigate quality issues, gather data, and conduct analysis to identify corrective actions.
- Manage CAPA workflows, ensuring ownership, approvals, and closure timelines are met.
- Monitor and communicate CAPA metrics, trends, risks, and improvement opportunities.
- Support delivery of QA engineering activities and CAPA training programs.
- Drive initiatives to improve QMS effectiveness and product quality.
- Provide quality and compliance support to manufacturing and operations teams.
- Support internal, customer, and regulatory audits and inspections.
Qualifications & Experience
- NFQ Level 7 degree (or equivalent) in Engineering, Science, Quality, or a related discipline.
- Minimum 3 years' experience in CAPA, Quality Assurance, or Quality Engineering.
- Medical device industry experience preferred.
- Knowledge of FDA 21 CFR Part 820, GMP, and ISO 13485:2016.
Key Skills
- Strong analytical, investigation, and problem-solving capabilities.
- Experience leading cross-functional projects and quality initiatives.
- Excellent communication and stakeholder management skills.
- Data analysis, reporting, and trend identification experience.
- Proficiency with quality tools, risk management, and continuous improvement methodologies.
