Quality Assurance Engineer

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.

Quality Department

We are looking for a meticulous and proactive QA Validation Process Team.

This role involves ensuring the accuracy and compliance of our tools and processes through rigorous validation and monitoring activities. Your contributions will be vital in maintaining the highest standards of quality and regulatory compliance.

Tasks and Responsibilities:

• Conduct MME tools calibration activities and update MME data on PLM.
• Perform internal verification of MME, including periodic calibration verification against primary standards.
• Execute environmental and water monitoring, including periodic monitoring and data verification.
• Perform statistical elaboration of data (validation data, periodic review data).
• Execute annual revalidation activities and review documentation.
• Update SOPs and QMS documentation.
• Conduct periodic internal inspections to verify compliance status of tools, equipment, and processes, and report findings.
• Support investigations related to nonconformances.

Job Requirements:

• Minimum of 2 years of experience in a similar position.
• Knowledge of ISO 13485, 21 CFR 820, MDR, and MDSAP; knowledge of ISO / IEC 17025 is preferred.
• Degree in a scientific discipline (Biomedical Engineering, Pharmaceutical Technologies, or equivalent preferred).
• 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.
• Experience with FDA / ANVISA / APAC Regulatory Inspections (if occurred during previous job experience).

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 energetic 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.

Quality Assurance • Pisa, Tuscany, Italy