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.
