Description:
The successful candidate will act as Quality Auditor and will the Quality Management System which includes the European Shared Service Centre located in Ireland and the European Distribution Centre located in Germany.
Responsibilities:
• Conduct Internal Audits.
• Assist in Regulatory and Corporate Audits.
• Provide Quality Systems support to all areas of the organisation.
• 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.
Qualifications:
• Third Level Qualification in Science or Engineering. Additional qualification in Quality/Validation/Statistics would be a distinct advantage.
• Proven knowledge and experience (min 4 years) of working with ISO13485:2003, ISO14971: 2000, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry.
• Qualified and experienced Lead Auditor, preferably within the Medical Device Industry.
• Strong interpersonal skills with the ability to communicate effectively at all organisational levels.
• German Speaker would be a distinct advantage.
Requirements:
• Spend time at the EUDC in Germany.
• Willingness to travel to conduct Vendor Audits
For a full Job Spec and further information please call Deirdre at 01 2784671 or e-mail your CV to dbolger@thornshaw.com
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