IVDR Assessor/Auditor

As part of our continued growth, we are looking to recruit technical and experienced In-Vitro Diagnostic Medical Device Assessors and Lead Auditors. The successful candidates will be responsible for planning and conducting audits / assessments against the manufacturing of medical devices, in accordance with ISO 13485, IVDR 2017/746 and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

Key Accountabilities: Assessor

• Conduct assessments (either desk-based or on client's sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer communication. 
• Conduct Technical File reviews specific for products being authorized. 
• Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. 
• Complete specific projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager.
• If required, undertake reviews of files and make certification decisions within target timescales and in line with DNV policies and accreditation/approval requirements.
• Conduct Technical File reviews specific for products being authorized. 

Key Accountabilities: Auditor

• Responsible to carry out audits of the manufacturer's quality management system (QMS) and of its suppliers and/or subcontractors when appropriate, and to draw up records and reports on the corresponding audits.
• Conduct surveillance audits including follow-up activities in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships. 
• Complete all chargeable work within the required timeframes to ensure customer satisfaction and efficiency of the business. 
• Complete projects in relation to IVDR procedures, processes, systems and documentation as requested by the Operations Manager.
• If required, undertake reviews of files and make certification recommendations within target timescales and in line with DNV policies and accreditation/approval requirements. 
• Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.