High Salary QA-RA Manager

2 weeks ago


Waterford, Ireland Berkley Group Full time

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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