Freelance Medical Devices Auditor/ For Long Projects

• Carry out the Audit and Training in compliance of requirements set in procedures, instructions, and other necessary documentations.
• Ensure that audit dates and duration of audit have been agreed with the client and that audits are carried out in a timely manner.
• Prepare Audit report in line procedural requirements, including classification of all/any non-conformities and submit it to the technical coordinator for review process.
• Coordination with all audit team members to agree a final recommendation, consistent with audit findings, including classification of all/any non-conformities.
• Follow-up of non-conformities, or re-audit where necessary, to ensure that they are closed out in line with SGS procedural requirements, using appropriate, competent audit team members where necessary.

• University or technical college degree in relevant sciences
• Relevant sciences such as: Biomedical engineering, Health technology, Mechanical engineering, Electronical engineering.
• 4 years of professional experience in relevant field
• Relevant industry such as: medical device industry and subcontractors, in vitro diagnostic industry and subcontractors, Sterilization department or sterilization service provider
• 2 years of the 4 of relevant professional experience shall be in quality management
• Relevant functions in quality processes related to MD such as: Quality engineer/manager, CAPA or complaint engineer / manager

• Appropriate knowledge of conformity assessment procedures laid down in medical device regulation 2017/745.
• Appropriate knowledge of medical devices quality management system ISO 13485:2016 and must hold IRCA approved ISO 13485:2016 lead auditor certification.
• Demonstrate 2 years working knowledge on MDT/MDA codes per Regulation (EU) 2017/ 2185 codes and 4 years of industrial working experience knowledge specifically for MDS 1004, MDS1009, MDS1010,
• knowledge of the standards such as cleanroom ISO 14644 series, biological evaluation ISO 10993 series, clinical investigation ISO 14155, risk management of medical devices ISO 14971 associated with the product covered by the MDA codes per regulation (EU) 2017/ 2185)
• Knowledge of MEDDEV 2.1/5 Medical devices with measuring function, IEC 62366-1 Medical devices—Application of usability engineering to medical devices
• Knowledge of IEC62304 Medical device software - Software life cycle processes either by intensive use or by training
• Knowledge of IEC/ISO 60601 – requirements for design of electrical and electromechanical medical devices to ensure safety and essential performance
• Knowledge of Directive 2006/42/EC either by intensive use or by training
• Appropriate knowledge of devices legislation as well as related harmonized standards, Common specifications (CS) and guidance documents
• knowledge on MDCG documents for medical devices.
• Knowledge of clinical evaluations for product categories covered by codes MDA per regulation (EU) 2017/ 2185.
• Knowledge of relevant products standards covered by the regulation (EU) 2017/ 2185 codes
• Must be able to demonstrate and excellent working knowledge of medical device management and regulatory systems, standards, and compliance/auditing techniques
• Effective interpersonal skills; able to develop good working relationships with people at all levels
• Must be IT literate i.e., competent in the use of MS Office applications and preferable experience of using large and complex databases
• Willingness to learn and adapt to change – committed to continuous personal and professional development
• Must have a detailed understanding of the relevant medical device regulations for which audits reviews are being undertaken

• Effective interpersonal skills; able to develop good working relationships with people at all levels
• Computer literacy, excellent communication, and presentation skills
• Technical knowledge and experience in related field and in using management methods and tools.

SGS