Our client, a medical device company in Galway are currently looking to recruit a Lead Auditor for their site.
The role is within Quality systems, with responsibilities for Quality Management, Internal and External Audits.
- Will act as an expert resource in external regulations and standards requirement - is viewed as a leader in the areas of ISO/MDD quality systems standards, constantly promoting awareness of best industry practices.
- Leads/manages internal audits of the Quality System that evaluate the adequacy and compliance of systems, and identify areas of potential noncompliance or improvements.
- Serves as a member of the audit team, participating in audits of varying complexity. Audit assignments are technical and complex in nature.
- Performs timely and adequate effectiveness checks and monitors corrective action progress for audit non-conformities.
- Leads/manages inspection activities of the Quality System related to regulatory agencies or notified bodies.
- To provide assistance and support to the engineering and operational functions on quality system requirements.
- Champions continuous improvement and innovation from a quality system perspective.
- Collect and analyze business/quality system process data from different parts of the company.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- May assist with development and maintenance of department metrics
- HETAC Level 8 qualification in a STEM discipline
- Qualified Lead auditor
- Expert knowledge in ISO 13485 or ISO 9001
- Decision making ability coupled with the ability to work on one’s own initiative and with minimum supervision is required.
- Good interpersonal skills and organisational skills.
- Excellent attention to detail.
- Valid EU work permit
For further information on this Lead Auditor role in Galway please contact Orla on 0860449473 / firstname.lastname@example.org
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