医疗器械审核员

Senior Project Engineer

Medical Devices are some of the most regulated products in the world. In this role, you will be a part of the UL Medical Regulatory Team. Working as the Auditor/Lead auditor with limited supervision, you will independently assist and support processing of manufacturer submissions to the ISO13485, MDSAP programs, UKCA Medical Device Regulation 2002, CE Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746. Within the framework of our highly regulated Medical Regulatory Programs you will:

• Support contract review / agenda setting for quality management system audits.
• Support regular quality system and technical audits, including CE, UKCA unannounced audits.
• Provide timely Audit Reports and customer Corrective and Preventive Action analysis and responses.
• Subject to training and qualification milestones, perform key Quality Management System audit activities to support safe products to market.
• Support Competent Authority activities on as needed basis e.g. Competent Authority audits of UL.
• Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job.
• Provide guidance and support to customers as required. Participate in client training and customer forums.
• National/International travel is required (50% to 75%).
• Product Reviewer (per MDR/IVDR) competencies and applications also welcomed.
• Performs other duties as directed.
• At least a Degree or equivalent in Life Science, Electrical / Electronics, Medical Laboratory Science, or Biomedical Engineering etc;
• Al Least four years' professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the area of quality management.
• Solid knowledge of Manufacturing methods for Medical Devices.
• Appropriate knowledge of devices legislation as well as related harmonized standards, CS and guidance documents;
• Appropriate knowledge and experience of risk management and related device standards and guidance documents;
• Appropriate knowledge of quality management systems and related standards and guidance documents;
• Appropriate knowledge and experience of the conformity assessment procedures in the listed programs (MDSAP, ISO13485, MDR, IVDR, etc), in particular of the aspects of those procedures for which they are responsible, and adequate authorization for carrying out those audits;
• Training in auditing techniques enabling them to challenge quality management systems;
• The ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
• Valid CNCA/CCAA auditor Registrations