QUALITY MANUFACTURING ENGINEER!

Want to join a motivated team of 100+ people who are dedicated to improving patient care through surgical robotics? Interested in working in the fast-paced, medical device industry? MMI is looking for people with a passion for innovation and a dedication to excellence.
MMI is seeking a Quality Manufacturing Engineer!   Core Responsibilities.
Maintain and Support Quality Management System with particular focus on manufacturing processes Coordinate and perform Quality Events and CAPA investigation activities Maintain Quality Events, CAPA and Complaints database updated Manage/Support inter-team Quality Events, CAPA and complaint related activities Support sustaining engineering to improve transfer to manufacturing process and tools development/validation, with related design documentation Support complaint intake, evaluation, and investigation activities Perform other related duties and responsibilities, as assigned.
Qualifications & Requirements.
Degree level qualification from a science/engineering background 3+ years’ experience in medical device or pharmaceutical industry with experience in Quality Assurance, Complaint Management, Medical Device or Healthcare.
Deep knowledge of ISO Experience with ISO Risk Management Good knowledge and experience of EU regulations Strong English verbal and written communication skills   Nice to have.
Experience working with class IIa / IIb Medical Devices Experience with IEC Medical Electrical Equipment, ISO Medical Device SW and ISO Usability.
Competence in mechanical and functional risk assessment Knowledge of complaint handling and reporting requirements as defined within the following.
21 CFR §803 (US), 21 CFR Part § (US), Canadian Medical Devices Regulations, SOR , MEDDEV / EUMDR, Japan MHLW Ministerial Ordinance No.
169, Taiwan Pharmaceutical Affairs Act article 45 and article 45-1, Section 41FN(3)(d) of the Therapeutic Goods Act complaint handling and reporting requirements, and ISO , Medical Devices – Quality Management System   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 ability to learn new skills under the direction of the Lead Quality Manufacturing & RA Expert with career advancement opportunities   Economic offer According to your experience and responsibilities we will give you;   Inclusive Welfare Plan; Ticket restaurant Company bonuses; Training plan; Work-life balance encouraged   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.