Microbiologist Biocompatibility Manager
Our mission is to create high-tech implantable devices and diagnostic solutions for cardiac diseases, accessible to the greatest number of people, while offering valuable services to patients, physicians, hospitals, and healthcare insurers.
The Microbiology department manages all Microbiological and Sterilization services for MicroPort CRM. As a patient-centric organization, 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 microbiological, sterilization, and biocompatibility services for MicroPort CRM and lead the Microbiology & Biocompatibility COE team.
Your Key Responsibilities:
* Define, supervise, manage, and review all microbiological analyses on products/semi-assemblies, components, supplies, etc. (e.g., sterility testing, bacterial endotoxins)
* Validate all sterilization methods processes according to applicable standards and manage the routine sterilization process
* Ensure compliance and monitoring of manufacturing areas to applicable standards classification (including hygienic rules definition for personnel and environment, cleaning solutions, and program)
* Manage internal and external Laboratories activities
* Act as a recognized expert in all Microbiology/Sterilization/Biocompatibility matters on new products development and business continuity (e.g., supplier/process changes) to all CRM sites
* Accountable for cleanroom qualification, monitoring (including trend analysis and management of nonconformities/CAPAs), and cleaning
* Define device cleaning process design and verification
* Define biological evaluation plan and report, as well as review biocompatibility test reports and chemical characterization/toxicological assessments
* Guarantee that all processes under responsibility are compliant to QMS requirements and GMP
* Act as subject matter expert for microbiology/sterilization/work environment/biocompatibility topics during internal/external audits
* Develop and manage the team acting as technical coach
* Develop, review, and approve quality system procedures, investigations (e.g., related to complaint or corrective and preventive actions), and audit responses
* Participate in Risk Management files preparation/update
* Provide/lead input to Cost improvement projects, including review and approval
* Prepare the budget to include expenses/acquisition of assets needed for microbiology and sterilization activities and monitor actuals versus approved budget
* Contribute to defining new product requirements, processes, or operational plans based on business strategy with significant impact on business results
* May manage projects or processes outside own job area
* Interact with internal and external customers and vendors at all levels
* Exercise 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 1993 series, etc.)
* Application of pertinent regulations (e.g., ISO 13485 and 21 CFR Part 820)
* People management skills
* English advanced level is a must
* Proficient in MS Office, including Word, PowerPoint, and Excel
* Excellent written and verbal communication skills
* Recognized expert managing large projects or processes
* Coaches and manages lower-level professionals
* Eight or more years of experience in a biomedical company or other FDA-regulated environment in an equivalent position
What We Offer:
We offer 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 what we do really makes a difference.
You will get the unique opportunity to work in a human-scale yet international organization and support life-saving products worldwide.
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.