Quality Documentation Engineer - ISO13485 Medical Devices

PROJECTUS; Toscana; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A medical technology company in Tuscany is looking for a Quality Documentation Engineer to support the development and compliance of medical devices. The ideal candidate should possess strong technical writing skills, a degree in science or engineering, and experience with class IIa/IIb medical devices. This full-time position requires fluency in English and Italian and knowledge of ISO 13485 and IEC 60601 standards.

Competenze

• Good technical writing skills in English and Italian.
• Experience working with class IIa / IIb Medical Devices.
• Deep knowledge of ISO 13485 and IEC 60601 standards.

Mansioni

• Review and issue technical documentation for regulatory compliance.
• Collaborate with cross-functional teams on product risk management.
• Support Electronics R&D with verification test plans.

Conoscenze

Technical writing skills

Knowledge of ISO 13485

Experience with class IIa / IIb Medical Devices

Experience with ISO 14971 Risk Management

Knowledge of IEC 60601 standards

Business fluent English

Formazione

Degree in science or engineering

Descrizione del lavoro

Quality Documentation Engineer - ISO13485 Medical Devices

QUALITY Documentation ENGINEER (ISO13485 MEDICAL DEVICES)

ASAP Start

OVERVIEW:

Would you like to embark on a thrilling journey with a passionate team dedicated to revolutionizing patient care through the power of surgical robotics?

Do you crave the fast-paced environment of the Surgical Robotics Industry?

Our client is seeking a remarkable individual with an insatiable passion for innovation and an unwavering commitment to excellence.

Join them as a Quality Design Engineer and be part of an exciting stage for our medical device client, at the forefront of breakthrough technology.

Are you driven by curiosity, always eager to learn and grow?

KEY ACCOUNTABILITES:

• Review and issuing of technical documentation, supporting development of DHF to ensure content is complete, accurate, and compliant with regulatory standards.
• Support the maintenance of user requirements, product requirements, product specifications and the traceability between product requirements, design and test items.
• Collaborates cross-functionally to support completion and maintenance of product risk management deliverables to establish and maintain safe and effective products and processes.
• Support the Electronics R&D Engineering team for developing verification test plans and reports
• Review of design control deliverables in compliance with IEC 80601-2-77, IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2
• Perform other related duties and responsibilities, as assigned (e.g. Support quality system-related deliverables, including nonconformances and CAPAs)

SKILLS/EXPERIENCE REQUIRED:

• Good technical writing skills (in English & Italian)
• Degree level qualification from a science/engineering background
• Experience working with class IIa / IIb Medical Devices
• Deep knowledge of ISO 13485
• Experience with ISO 14971 Risk Management
• Deep knowledge of IEC 60601* standards
• Basic knowledge and experience of EU and US regulations
• Business fluent English speaking skills (B2 at least)

OTHER INFORMATION:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance and Engineering
• Industries: Medical Equipment Manufacturing, Electrical Equipment Manufacturing, and Automation Machinery Manufacturing

We are an equal opportunities employer and welcome applications from all qualified candidates.