Microbiologist Biocompatibility ManagerOur mission is to strive to create high-tech implantable devices and diagnostic solutions for cardiac diseases, which are accessible to the greatest number of people, while offering valuable services to patients, physicians, hospitals and health care insurers.The Microbiology department manages all Microbiological and Sterilization services for MicroPort CRM. As for us the patient always comes first, we strive daily to deliver medical devices for heart related conditions that help people live longer and healthier lives.In our plant, based in Saluggia, we are looking for a Microbiologist Biocompatibility Manager, to provide to manage all microbiological, sterilization and biocompatibility services for MicroPort CRM and lead the Microbiology & Biocompatibility COE team.Your missions will be as follows:Be responsible define, supervise, manage and review all microbiological analyses on products/semi assemblies, components, supplies, etc. ( e.g. sterility testing, bacterial endotoxins) Validate all the sterilization methods processes according to applicable standards and manage the routine sterilization processBe responsible of the compliance and monitoring of manufacturing areas to the applicable standards classification (this includes hygienic rules definition for personnel and environment, cleaning solutions and program) Be responsible of the internal and external Laboratories activitiesAct as recognized master in all Microbiology/Sterilization/Biocompatibility matters on new products development and on the business continuity (e.g: supplier/process changes) to all CRM sitesAccountable for the cleanroom qualification, monitoring (including trend analysis and management of nonconformities/CAPAs) and cleaningDefine the device cleaning process design and verificationDefine the biological evaluation plan and report, as well as review biocompatibility test reports and chemical characterization/toxicological assessmentsGuarantee that all processes under her/his responsibility are compliant to QMS requirements and GMPAct as subject matter expert for microbiology/sterilization/work environment/biocompatibility topics during internal/external auditsDevelop and manage the team acting as technical coach.Develop, review and approve quality system procedures, investigation (e.g., related to complaint or to corrective and preventive actions) and audit responses Participate to the Risk Management (RM) files preparation/updateProvide/lead input to Cost improvement projects, including review and approval Prepare the budget to include expenses / acquisition of assets that are needed for the activities linked to the microbiology and sterilization and monitor actuals versus the approved budgetContribute to defining new products requirements, processes or operational plans based on business strategy with a significant impact on the business results May manage projects or processes that go outside his/her own job areaInteracts with internal and external customers and vendors at all levelsExercises significant latitude in determining deliverables of assignments, with very limited oversight from manager Your profile: Master degree in Biology, Biotechnology or Science.Proficiency knowledge of pertinent standards related to microbiology, sterilization, environmental control and biocompatibility (e.g.: ISO 11135.ISO 14644-1&2,ISO 14698-1&2, ISO 11737-1&2, ANSI AAMI ST72, ISO 01993 series, etc.) to assure the process/documentation meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfilling such requirementsApplication of pertinent regulations (e.g., ISO 13485 and 21 CRF Part 820) People management skillsEnglish advanced level is a mustProficient in MS Office including Word, Power Point, and ExcelExcellent written and verbal communication skills Recognized expert, managing large projects or processes Coaches and manage lower levels professionalsEight or more years of experience in a biomedical company or other FDA-regulated environment in an equivalent positionWhat we offerOf course, there are compensation, various benefits, career opportunities and the whole package you usually find in a company. What really matters in the end is why we come to work every day and that what we do really makes a difference.Unlike similar positions in larger companies, you will get the unique opportunity to work in a human scale yet international organization and support life-saving products all over the world.If you have “eyes for greatness, hands on details”, then you can make a difference inside our company! Each of us at Microport CRM is here to help people live longer and healthier lives no matter which is our expertise.