Lead Auditor – Active Medical Devices – Software AI

Kiwa Italia; Frosinone; In loco; EUR 40.000 - 55.000; Tempo pieno

Descrizione del lavoro

Join a leading TIC company as a Product Assessor / Lead Auditor for Medical Devices Software. You will conduct audits, review compliance with regulations, and travel extensively for client engagements. We're looking for a Master's degree holder with minimum four years in the medical device sector and experience in software.

Servizi

Competitive salary package based on experience

Company car for personal and business use

Meal vouchers and performance bonuses

Private health insurance

Flexible working hours

Additional leave for medical appointments

Comprehensive onboarding and ongoing training programs

Competenze

• Minimum four years experience in medical devices, especially software manufacturing.
• Experience in designing and programming embedded or standalone software is preferred.

Mansioni

• Conducting audits at client sites for compliance with MDR, ISO 13485.
• Managing quality management system audits for manufacturers of active medical devices.
• Reviewing technical documentation per relevant directives.

Conoscenze

Knowledge of Directive 93/42/EEC

Quality Management Systems

Excellent command of English

Familiarity with ISO 13485

Knowledge of Artificial Intelligence

Formazione

Master's Degree in Electronic Engineering or Computer Science

Descrizione del lavoro

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

Kiwa, a global leader in Testing, Inspection, and Certification (TIC), is seeking a qualified Product Assessor / Lead Auditor specialized in Active Medical Devices Software. This role is within our Medical Division, which boasts extensive experience in medical device certification worldwide.

Role Description:

As a Lead Auditor, you will be responsible for conducting audits at client sites and manufacturing facilities of active medical devices/software, ensuring compliance with Medical Device Regulations (MDR), Directive 93/42/EEC, and ISO 13485 standards. After completing internal training, your tasks will include:

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

Candidate Requirements:

• Master's Degree in Electronic Engineering, Computer Science, or related fields.
• Minimum four years of professional experience in the medical device sector, especially in manufacturing of electro-medical devices (software), with knowledge of Directive 93/42/EEC, quality, production, design, and testing areas.
• Preferred: Experience in designing and programming standalone or embedded software in active medical devices.
• Knowledge of Artificial Intelligence and experience working with AI-based 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.

What We Offer:

• Competitive salary package aligned with experience and skills.
• Company car for business and personal use.
• Meal vouchers, performance bonuses, and annual welfare benefits.
• Private health insurance.
• Flexible working hours.
• Additional leave for medical appointments.
• Comprehensive onboarding and ongoing training programs.

Join our friendly, professional Medical Devices team at Kiwa, comprising over 40 highly qualified colleagues. The role involves frequent travel but allows remote back-office work. You will report to the Technical Division Manager.

At Kiwa, we operate across diverse markets, including management system certification, product certification, corporate social responsibility, testing, and metrology. With over 10,000 employees in more than 40 countries, and part of the SHV Group since 2021, we are committed to professional development and personal well-being.