Quality Assurance Engineer

3 settimane fa


Pisa, Toscana, Italia MMI - Medical Microinstruments, Inc. A tempo pieno
Want to join a motivated team of 220+people who are dedicated to improving patient care through surgical robotics? Interested in working in the fast-paced medical device industry?
Medical Microinstruments Inc is looking for people with a passion for innovation and a dedication to excellence.

At MMI we are building the future of microsurgery. The Symani platform provides the surgeon with the capability to operate on a small scale with ease and precision, thanks to the Symani platform and a variety of Instrument types.
For our

Quality Department

, we are seeking a dedicated and detail-oriented

QA Engineer

to join our QA Platform Team

.

In this role, you will play a crucial part in ensuring the quality and compliance of our manufacturing processes and products. Your expertise will support validation activities, tool management, and the maintenance of our Quality Management System (QMS).

Role Purpose:
Support validation activities and tool management.
Maintain the Quality Management System (QMS) with a focus on manufacturing processes.
Manage QMS documentation and production documentation related to manufacturing processes (DHR Review).
Assist in investigations related to nonconformances.
Perform final visual inspections on platform devices.

Job Requirements:
Minimum of 2 years of experience in a similar position.
Knowledge of ISO 13485, 21 CFR 820, MDR, and MDSAP.
Degree in a scientific discipline.
Excellent knowledge of the English language.
Proficiency in Microsoft Office tools.
Familiarity with or willingness to learn management systems (PLM, ERP, etc.).
Strong teamwork and communication skills.
Result-oriented mindset.
Good understanding of quality management system analysis and improvement processes.
Nice to Have:
Experience with ISO 14971 Risk Management.
Experience with Class IIa/IIb Active Medical Devices.
Experience with IEC 60601 Medical Electrical Equipment.
Knowledge of ISO 19011.

About MMI
MMI is dedicated to improving reconstructive options for surgeons and patients and has developed the first teleoperated robotic platform for open microsurgery. It offers the surgeon motion scaling and tremor elimination and aims to facilitate existing procedures as well as enable new ones in the domain of microsurgery, from post-oncological and trauma reconstructions to ophthalmology, organ transplantation and pediatric surgery.

What we offer
An exciting and challenging role based in Pisa, Italy. Working in a fun and growing company that is dedicated to improving patient care. The chance to learn new skills under the direction of experienced colleagues with career advancement opportunities.

Join Us
Are you seeking an opportunity to make a real difference in a med-tech company with the aim of improving patient care?
Join us and grow with a team of energy people who will motivate and inspire you
Interested? We would love to hear from you

MMI is committed to creating a diverse work environment and is proud to be an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, pregnancy, age, disability or other characteristics protected by law.

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