Site Quality and Regulatory Manager

Our client, a leading Medical Device CMO and the partner of choice for innovative technologies and services is looking for a Site Quality and Regulatory Manager to lead the quality function at their Galway site.

The Site Quality and Regulatory Manager will primarily be responsible for developing and maintaining world class quality systems related to development and manufacture while developing employee efficiencies. This includes developing and leading a strong quality team to best-in-industry standards, supporting the achievement of all day to day production targets and supervision of quality engineers to ensure compliance for their areas of responsibility. 

The Site Quality and Regulatory Manager will also supervise documentation control personnel to ensure compliance for their areas of responsibility and be accountable for Design Assurance. The Site Quality and Regulatory Manager Manager will be responsible for regulatory affairs through ensuring regional compliance to all relevant regulations and being an active member of the R&D group design phase reviews, ensuring compliance to standards as well as the supervision of regulatory personnel to ensure compliance for their areas of responsibility.

The Site Quality and Regulatory Manager will be an active member of the management team and work with all other managers and directors and staff to develop a world class lean manufacturing system and constantly strive to deliver quality products in an environment focused on throughput increase, inventory reduction and operational expense reduction.

In addition the Site Quality and Regulatory Manager will be the company's Management representative and will ensure that the quality system is established, implemented and maintained in accordance with ISO 13485 and will report on the performance of the quality system to senior management for reviews which will act as the basis for improvements.

Requirements:

Contact Nicole O'Connor for a confidential discussion on this role.

Email: nicole@fastnettalent.com

Telephone: +353 21 4670640

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