Company: Thornshaw Recruitment
Closing Date: 18 Nov 16
Salary (£): Negotiable
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
• 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 email@example.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. Www.thornshaw.com Tel: +353 1 2784671
Barton House 6 Old Dublin Road Stillorgan Co. Dublin
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