We are seeking a seasoned Quality Assurance Professional to join our team in Galway. The ideal candidate will be based onsite and support production operations.
This role involves providing quality assurance support to manufacturing processes, ensuring compliance with regulatory standards and internal procedures. Responsibilities include auditing, documentation management, non-conformance handling, and supporting process improvements within a regulated environment.
Main Responsibilities:
* Provide day-to-day quality support to production teams.
* Conduct audits of manufacturing processes, materials, and equipment.
* Manage non-conforming materials and implement corrective actions.
* Maintain and update Quality Management System (QMS) documentation.
* Ensure compliance with GMP and GDP regulations.
* Prepare and report quality metrics and performance indicators.
* Support validation, product transfer, and audit activities.
* Contribute to continuous improvement initiatives using Lean and Six Sigma methodologies.
Required Qualifications and Experience:
* Third-level qualification in a quality-related discipline or equivalent experience.
* 2–5 years' experience in quality assurance or operations within the medical device or pharmaceutical industry.
* Familiarity with ISO 13485, EU MDR, and FDA 21 CFR Part 820 regulations.
* Experience in documentation control and auditing.
* Proficiency in Microsoft Office applications.
* Excellent communication, organization, and problem-solving skills.