AUDITOR (QUALITY) – Donegal
Our client, a multinational medical devices company who employ almost 4,000 people in Ireland across 6 sites. This role, based at their Donegal site is essentially a Quality Engineer role whose prime responsibility is Auditing. You will lead a comprehensive Quality Audit Service at the site; ensuring compliance to the QMSM and the Corporate, Division, Site and worldwide regulatory requirements that apply to the Donegal site. As the site Auditor you will be focused on Internal Audits, Focus Audits and External Audit management.
MAJOR RESPONSIBILITIES INCLUDE:
- Responsible for the Global Audit program at the site.
- Build positive relationships and coordinated communications to site leadership team.
- Lead all scheduled internal, external and focused audits ensuring integrity and compliance with auditing requirements.
- Support the CAPA process by reviewing and approving all related CAPA audit activities.
- Track and Trend Audit related data as required.
- Site metric owner for any Audit metrics and KPI’s.
- Collaborate with the Division Manager in developing Auditor training, maintain awareness of changes to applicable standards and regulations and implement improvements.
- Maintain a high awareness of industry developments, particularly in the area of audit compliance and FDA communications.
- Provide status updates to relevant functions/external agencies on any observation and concerns noted and ensure timelines committed are met and audits/inspections closed.
- Responsible for compliance with applicable Corporate and Divisional policies and performing other duties as assigned by management.
EDUCATION AND BACKGROUND:
- Certified Lead Auditor (ISO 13485)
- A relevant third level qualification in Quality/Engineering/Manufacturing/Science.
- 2 years’ relevant experience in a Quality/Engineering/Manufacturing/Science environment.