Site Quality and Regulatory Manager

  • Galway
  • Permanent
  • JO-1906-64579_1566376930

Summary

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 QA & RA Manager will also supervise documentation control personnel to ensure compliance for their areas of responsibility and be accountable for Design Assurance. The QA & RA 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 QA & RA 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 focussed on throughput increase, inventory reduction and operational expense reduction.

In addition the 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:

  • Engineering or science Degree preferably with Quality Engineering included.
  • Qualified systems lead auditor for ISO 13485 and MDD compliance.
  • Several years' experience in the Medical Device industry including a minimum of three years' experience in design assurance/quality/regulatory function.
  • Experience with USA regulatory requirements would be advantageous.

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