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QUALITY LEAD AUDITOR/ENG
Company:HARMONICS RECRUITMENT & SEARCH |
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Job Reference Number |
14572174 |
Client ID: |
RI/83054 |
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Posted On: |
Feb 22 2012 |
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Location: |
CLARE, LIMERICK |
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Job Type: |
Permanent |
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Salary: |
COMPETITIVE |
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Benefits: |
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Our Multinational Healthcare Client has a requirement for an experienced Quality Lead Auditor/Engineer . This is a new role that has opened up as a result of expansion and would suit someone with a strong quality background seeking a varied role. A Lead Auditor Qualification is essential when applying for this role.
Duties:
- Conduct Internal Audits at the site and assist in Regulatory and Corporate Audits.
Provide Quality Systems support to all areas of the organisation, ensuring compliance is maintained at all times.
Prepare data for monthly Quality Review meetings.
Provide input and support to the Corrective and Preventive Action program (CAPAs), the Non-Conforming Product Process.
Provide Quality training to new staff, including the Quality Manual.
Perform European Vendor Audits.
Prepare, implement and analyse key Quality Systems related documentation.
Provide meaningful Quality measurement while ensuring that in-house or external Quality issues are effectively prioritised and acted upon in a timely manner.
Provide inputs to the KPI’s and Management Review.
- Third Level Qualification in Science or Engineering.
Additional qualification in Quality/Validation/Statistics would be an advantage.
4+ years working within an FDA regulated facility essential
Qualified and experienced Lead Auditor, preferably within the Medical Device Industry.
Strong interpersonal skills with the ability to communicate effectively at all organisational levels.
