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.
Meet the team: Are you looking to leverage your experience to be part of something big and help people take control of their health? Do you enjoy building and managing relationships to better understand the needs of the business, and then creating and implementing solutions to meet those needs? Do you want to be part of a high-performing team dedicated to doing the right thing? If so, then we have an opening for you!
Our Quality Assurance team is looking for a dynamic and skilled Microbiology Supervisor (Onsite role) to support the start-up of our first European manufacturing site in Athenry. In this role, you will be responsible for ensuring compliance with domestic and international standards regarding the 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: Select, develop, and evaluate personnel to ensure the efficient operation of the function.Supervise daily operation of the Microbiology laboratory.Ensure testing requirements for the environmental monitoring program comply with current domestic and international standards.Establish and maintain the environmental monitoring program for the Heating Ventilation & Air Conditioning (HVAC), Compressed Gas Systems, and Pharmaceutical Grade Water Systems.Support design and process improvements by providing guidance and testing support in relation to sterilization, bioburden, biocompatibility, cleaning validation, and test method validations.Support product release testing (i.e., endotoxin).Establish and maintain environmental monitoring excursion communication, reporting, investigation, disposition, and corrective action processes. Requires multi-department communication and approval for coordination of work performed (i.e., Operations, Facilities, and QA).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.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.Solid understanding of international and domestic medical device GMPs/Quality System Requirements.Solid understanding of international and domestic environmental monitoring requirements.Travel Required: 10%
#J-18808-Ljbffr
