
High Salary QA-RA Manager
2 weeks ago
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- 13485 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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