Join Kiwa, a global leader in Testing, Inspection, and Certification (TIC). We are seeking a Product Assessor / Lead Auditor for Active Medical Devices Software to ensure the proper execution of technical activities and evaluations in accordance with relevant rules and procedures.
Role Description :
As a Lead Auditor, you will be responsible for conducting audits at clients and manufacturers of active medical devices / software, in compliance with the Medical Device Regulations (MDR), Directive 93 / 42 / EEC, and ISO 13485 standards.
After internal training, your tasks will include :
* Managing the entire quality management system audit process for manufacturers and suppliers of active medical devices, ensuring smooth operations
* Performing audits at clients ranging from innovative startups to large national and international companies with diverse medical devices
* Reviewing technical documentation in line 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 fields
* Minimum four years of professional experience in the medical sector, particularly in manufacturing of active electronic medical devices (software) per Directive 93 / 42 / EEC, including quality, production, design, and testing areas
* Preferably, experience in designing and programming standalone or embedded medical device software
* Knowledge of Artificial Intelligence and experience working with AI-enabled software is a plus
* Familiarity with ISO 13485, ISO 9001, and ISO 14971 standards
* Willingness to travel frequently (domestic and international)
* Excellent command of English
Benefits :
* Company car for personal and professional use
* Performance bonuses and annual welfare benefits
* Supplementary health insurance
* Additional leave for medical appointments
* Comprehensive onboarding and ongoing training
Join our Medical Devices team, a friendly, cohesive, and professional group of over 40 highly qualified colleagues. While frequent travel is required, back-office tasks can be performed remotely. You will report to the Technical Division Manager.
At Kiwa, we operate across various market segments, including management system certification, product certification, corporate social responsibility, testing, and metrology. With over 10,000 employees in more than 40 countries, mainly in Europe, Asia, America, and Oceania, Kiwa has been part of the SHV Group since 2021.
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