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Medical Device Auditor

Posted 25 January by Reed Scientific Easy Apply Featured Ended
REED Scientific is recruiting for a Medical Device Auditor to join a global organisation. The successful candidate will be responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

Main Responsibilities:
• Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships
• Conduct Technical File reviews specific for products being authorized
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business
• Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by medical devices operations manager
• Ensure completion of all assigned work and relevant documentation in accordance with required procedures and standards to fulfil customer expectations
• Provide accurate and timely reporting as required by line management to assist the planning and management of operations
• If required undertake reviews of packs and make certification decisions within target timescales and in line with policies and accreditation/approval requirements
• Manage personal schedule to work efficiently and to meet target chargeability requirements as defined by the Certification Manager
• Project-manage auditing teams, as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards
• Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant auditor registrations and relevant industry knowledge
• If required, to provide technical support and staff training to all parts of the business in UK and overseas to enhance the service capability of the business
• Support business development activities as required (including follow up and/or referral of enquiries, sales visits, assistance at events, seminars, etc) to enable on-going growth of the business

• The successful candidate will have at least 4 years’ experience working within the medical device industry.
• You will have an excellent working knowledge of ISO 13485, MDD 93/42/EEC
• You will have good manufacturing and technical knowledge of electro-medical devices, sterilization and non-active devices and their relevant harmonized standards.
• You will have experience conducting MDSAP audits

For more information or to apply for this position, please contact Greg Robertson or email Please note that your CV should be in WORD format and no longer than 2 pages.

REED will send your application to

Reed Specialist Recruitment Limited is an employment agency and employment business

Reference: 34323256

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