Overview
Our client is seeking a talented individual to join us as QA/RA Manager.
This role will be based onsite in Dungarvan, County Waterford, and you will play a pivotal role in ensuring implementation, maintenance, and compliance to regulatory standards.
Responsibilities
Developing and maintaining world class quality systems related to the development and manufacture of Class 1/ Class 2 medical and surgical textiles.
Control of Quality Systems to ensure compliance to US FDA 21 CFR Part 820, MDD, MDR, ISO and ISO-14001.
Work proactively and collaboratively with colleagues internationally.
Establishment of Quality Objectives - tracking and reporting of quality performance against customer and company objectives.
Act as the Site Management Representative.
Act as the site 'Person Responsible for Regulatory Compliance' (PRRC)
Developing and leading a strong quality team to best-in-industry standards.
Supporting the achievement of all day-to-day product shipment targets
Liaising with external parties on matters relating to the quality management system
Scale up quality compliance operations to support EU growth.
Provide strategies to address compliance gaps and enhance quality systems.
Key Skills & Experience
Engineering, chemistry, or life science Degree preferably with QMS included.
Qualified systems lead auditor for ISO 13485 and MDR compliance.
Knowledge of QA/RA regulatory compliance, MDR and FDA, ISO 13485, GMP and ISO 14001.
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