Lead Auditor – Active Medical Devices – Software AI

Join Kiwa as a Product Assessor / Lead Auditor for Medical Devices Software

Kiwa, a leader in Testing, Inspection, and Certification (TIC), is seeking a skilled Product Assessor / Lead Auditor to join our Medical Division, with a global presence and extensive expertise in medical device certification.

Role Description:

As a Lead Auditor, you will be responsible for conducting audits on clients and manufacturers of active medical devices/software, ensuring compliance with Medical Device Regulations (MDR), Directive 93/42/EEC, and ISO 13485 standards. After internal training, your duties will include:

• Managing the entire quality management system audit process for manufacturers and suppliers of active medical devices
• Performing audits for a diverse range of clients, from innovative startups to large international companies
• Reviewing technical documentation in accordance with MDR and Directive 93/42/EEC
• Maintaining regular contact with clients regarding audit activities and follow-ups
• Collaborating with colleagues within your area of expertise
• Traveling domestically and internationally up to 70% of the time

Qualifications:

• Master's degree in Electronic Engineering, Computer Science, or related field
• At least four years of professional experience in the medical sector, especially in manufacturing of electromechanical medical devices (software) per Directive 93/42/EEC, including quality, production, design, and testing areas
• Experience in designing and programming standalone or embedded medical device software is a plus
• Knowledge of Artificial Intelligence and experience working with AI software is advantageous
• Familiarity with ISO 13485, ISO 9001, and ISO 14971 standards
• Excellent command of English

Benefits:

• Company car for personal and professional use
• Meal vouchers
• Performance bonuses and annual welfare programs
• Supplementary health insurance
• Flexible working hours
• Additional leave for medical visits
• Ongoing training programs

This role offers an exciting opportunity to work within a dynamic, international team of over 40 professionals, with frequent travel opportunities across Italy and abroad. Remote work is possible for back-office activities. The position reports to the Technical Division Manager.

Join Kiwa and be part of a global organization operating across multiple market segments, including management system certification, product certification, CSR, testing, and metrology. With over 10,000 employees in more than 40 countries, Kiwa is committed to your professional growth and well-being.