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Quality Systems Engineer

Reference:CC/HQ00001648 Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Quality Systems Engineer

Our multinational medical device client in Limerick requires a permanent Quality Systems Engineer. Reporting to the Quality Systems Manager the primary function of this role is to act as Quality Auditor. The responsible person will also assist in the implementation and improvement of all aspects of the quality management system.

• Maintain the Internal Audit System acting as the Quality Auditor with a team of Internal Auditors.
• Conduct in-depth Internal Audits of all aspects of the QMS against the relevant regulations.
• Detailed knowledge of the Medical Device regulations, guidance and requirements.
• Ability to implement and improve a QMS.
• Organise and manage site preparation for Regulatory and Corporate Audits.
• Manage Audit back rooms for Regulatory and Corporate Audits.
• Provide Quality Systems support to all areas of the QMS, ensuring compliance is maintained at all times.
• Conduct Supplier audits.
• Ability to lead and drive assigned Process Improvements essential.
• Prepare, implement and analyse key Quality Systems related documentation.
• Provide input and support to the Preventive Action (CAPA) program.
• Provide training on the Quality Manual and other key Quality Systems procedures.
• Prepare Management Review presentations as appropriate.
• 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 KPI’s and Management Review.

• Third Level Qualification in Quality, Science or Engineering.
• 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.
• High attention to detail in all aspects of the role.
• Good working knowledge of Microsoft Office.

If you would like further Information you can contact the recruiter directly:

Conor Cronin | Tel: +353 (0) 1 5079258