Job Description
The Company Dexcom Corporation (NASDAQ DXCM; Market Cap $44.3B) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by nearly 10,000 ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Our Quality Assurance team is looking for a dynamic and skilled Microbiology Supervisor to support the start-up of our first European manufacturing site in Athenry. In this role, you will be responsible for ensuring compliance to domestic and international standards with regards to day-to-day operation of the Microbiology laboratory, the monitoring of environmental systems (i.e. HVAC/cleanroom, Compressed Air, Water), sterilization of medical devices, biocompatibility testing of materials as well as the supervision and training of laboratory technicians. Where you come in: You will select, develop and evaluate personnel to ensure the efficient operation of the function. You will supervise daily operation of the Microbiology laboratory. You will ensure testing requirements for the environmental monitoring program complies to current domestic and international standards. You will establish and maintain the environmental monitoring program for the Heating Ventilation & Air Conditioning (HVAC), Compressed Gas Systems and Pharmaceutical Grade Water Systems. You will support design and process improvements by providing guidance and testing support in relation to sterilization, bioburden, biocompatibility, cleaning validation and test method validations. You will support product release testing (i.e. endotoxin). You will establish and maintain environmental monitoring excursion communication, reporting, investigation, disposition and corrective action process. Requires multi-department communication and approval for coordination of work performed (i.e. Operations, Facilities and QA). You will maintain compliance of the sterilization program for sterile implantable devices by performing scheduled re-qualification, supplier audits, new product qualifications, challenge and bioburden testing when necessary. What makes you successful: Typically requires a Bachelor’s degree with 5-8 years of industry experience. Informal management/team lead experience. Knowledge and understanding of Product and Material Sterilization, Biocompatibility and Cleanroom Microbiology. You must have knowledge of the following: 21 CFR 820, ISO 13485, CMDR, and EEC93/42, U.S. and E.U. Pharmacopeia, International Organization for Standardization (ISO) 10993, 14644, 14971 and other Risk guidance standards to create the processes and supporting documentation. You have a solid understanding of international and domestic medical device GMPs/ Quality System Requirements. You have a solid understanding of international and domestic environmental monitoring requirements. What you’ll get: A front row seat to life changing CGM technology. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 10% To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. #J-18808-Ljbffr