Lead Auditor – Active Medical Devices – Software AI

Kiwa Italia; Pavia; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

Kiwa Italia is seeking a Lead Auditor for Medical Devices Software to join their Medical Division. The role involves conducting audits, managing quality systems compliance, and requires a Master’s Degree and experience in electro-medical device manufacturing. Join a highly qualified team with opportunities for travel and professional growth.

Servizi

Company car

Meal vouchers

Performance bonuses

Health insurance

Flexible working hours

Remote work options

Additional leave for medical visits

Training programs

Family benefits

Competenze

• At least four years of professional experience in the medical field, particularly in manufacturing of electro-medical devices.
• Experience in quality, production, design, and testing areas.
• Knowledge of ISO 13485 and ISO 9001 standards.

Mansioni

• Managing the entire quality management system audit process for medical device manufacturers.
• Performing audits at diverse clients including startups and large corporations.
• Maintaining regular contact with clients regarding audit activities.

Conoscenze

Project Management

Quality Management

Technical Documentation Review

Risk Management

Bilingual (Italian and English)

Formazione

Master's Degree in Electronic Engineering

Master's Degree in Computer Science

Descrizione del lavoro

Join Kiwa as a Lead Auditor for Medical Devices Software

Kiwa, a global leader in Testing, Inspection, and Certification (TIC), is seeking a Lead Auditor for Medical Devices Software within our Medical Division. This role ensures the proper execution of technical activities and evaluations in compliance with applicable rules and procedures.

Role Description: As a Lead Auditor, you will be responsible for conducting audits at client sites and manufacturing facilities for active medical devices and software, according to MDR regulations and medical device directives, following industry standards.

After internal training, your responsibilities will include:

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

Requirements:

• Master's Degree in Electronic Engineering, Computer Science, or related field.
• At least four years of professional experience in the medical field, particularly in manufacturing companies of electro-medical devices (software) under Directive 93/42/EEC, and in quality, production, design, and testing areas.
• Preferred: Experience in designing and programming active medical devices.
• Knowledge of AI software is a plus.
• Understanding of ISO 13485 and ISO 9001 standards.
• Experience in risk management per ISO 14971.
• Familiarity with MDR and Directive 93/42/EEC regulations.
• Willingness to travel frequently (up to 70%).
• Excellent proficiency in Italian and English.

We Offer:

• An exciting position within an ambitious, internationally oriented organization.
• A competitive salary package based on experience and skills.
• Benefits including company car, meal vouchers, performance bonuses, health insurance, flexible working hours, remote work options, additional leave for medical visits, training programs, and family benefits.

You will be part of Kiwa's Medical Devices team, a friendly, professional, and highly qualified group of over 40 members. The role involves frequent travel in Italy and abroad, with remote back-office work possible. The position reports to the Technical Division Manager.

Join us at Kiwa, a company operating across various markets, including management system certification, product certification, CSR, testing, and metrology. With over 10,000 employees in more than 40 countries, Kiwa is part of the SHV Group since 2021.