Medical Device Lead Auditor - USA
Medical Device Lead Auditors - USA (America).
Salary: 85-105K USD.
Location: Anywhere USA.
Main Purpose of Role:
• To plan and conduct professional management system audits in accordance with procedures to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards
• To assist in business development as required and to provide specific technical support to expand the Company’s capability to offer valued services to customers
• To carry out specific project tasks in relation to medical devices procedures, processes, systems and documentation.
• Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery.
• Conduct Technical Files review specific for products being authorized for
• 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.
• If required undertake reviews of packs and make certification decisions within target timescales.
• 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.
• If required, to provide technical support and staff training to all parts of the business in the USA and overseas to enhance the service capability of the business
• Must be able to demonstrate and excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.
• Must be able to demonstrate a good knowledge of
• Electro-medical devices (active devices); and/or sterilization and non active devices
• Good experience with EN ISO 60601-1 3rd Edition and relative amendment; and/or Harmonised sterilization and cleanroom and on active medical device standards.
• Good experience with Risk Management EN ISO 14971:2012
• Good knowledge of ISO 13485, MDD 93/42/EEC and their application
• Good knowledge of Usability / Software standards such as 60601-1-6, 62366, 62304 and/or clean room and sterilization product standards.
• Registered lead auditor, or equivalent registration under other recognised body (Desirable on entry, Essential within one year)
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- Medical Devices
- Certified Lead Auditor
- ISO 13485
- Quality Management Systems
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