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Job Details

Quality Systems Auditor

Company: Thornshaw Recruitment
Reference: SM9174
Closing Date: 18 Nov 16
Type: Permanent
Salary (£): Negotiable

Job Summary:

On behalf of our client, a global medical device company, we are recruiting for a Quality Systems Engineer/ Quality Auditor.


Responsibilities of the role will include the following: 
• 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. 
• Provide Quality Systems support to all areas of the QMS, ensuring compliance is maintained at all times. 
• Conduct Supplier audits. 
• Prepare, implement and analyse key Quality Systems related documentation. 
• Provide input and support to the Company Corrective and Preventive Action (CAPA) program. 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. 

Applications are invited form candidates with the following background and experience: 
• 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. 
• The ability to challenge thinking/opinion/actions in light of ensuring Company Quality Systems is adhered to. 
• High attention to detail in all aspects of the role. 
• Excellent organisational skills. 
• Proven problem-solving skills. 
• High self-motivation. 
• Good working knowledge of Microsoft Office. 
Willingness and availability to travel on company business

For more information and to apply for this role please call Stephanie on +353 1 2784671 or e-mail 

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Tel: +353 1 2784671

Apply for this job: Quality Systems Auditor

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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