Senior QA Manager (Quality Systems)

The Company Dexcom Corporation (NASDAQ DXCM) 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 thousands of 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. Meet the team :   Are you   seeking   to   demonstrate   your   expertise   to   give   something significant and   assist   individuals in handling their health? Do you enjoy encouraging and handling relationships to gain a deeper understanding of the business's requirements, and then crafting and implementing solutions to fulfill those requirements? Do you wish to be part of a top-performing team committed to ethical practices? If yes, then we have an opportunity for you!   Our Quality Assurance team are looking for the right teammate to support our European manufacturing site in Athenry.   As   Senior   QA Manager, you will manage the development and implementation of the organization’s quality policies and programs.   You will also   be responsible for   ensuring systems   comply with   FDA and ISO quality system regulations.   Where you come   in :     The   Senior   QA Manager provides support for the projects, functions, and strategic   objectives   of Quality System Compliance (Audit/CAPA/NCMR /Internal Audit/Management Review ) and the document control area.   You are a strong tactical decision-maker,   handles   unforeseen issues as they relate to Dexcom’s compliance with regulations and conformance to required regulations.   You regularly interact with senior management or executive   levels on matters   regarding Dexcom’s compliance with regulations and conformance to required regulations.   You   are responsible for   the   area   operational management with   a track record   of working/supporting high volume manufacturing.   You design and   maintain   the quality system according to written policies and procedures.   You understand domestic and international Quality System Requirements and how they interact to be able to   provide   quality guidance to other departments and companies. Must have the ability to change the thinking of, or gain acceptance   from,   others in sensitive situations, without damage to the relationship.   You   establish   operational   objectives   and work plans for the Quality Department and delegates assignments. Specifically, assuring your team are meeting sustai ning &   development project deliverables, creating communication between cross-functional departments,   participating   in process or product investigations,   identifying   potential root   causes   and providing business solutions. You exercise supervision in terms of costs, methods, and staffing.   You l ead the team that manages projects and non-conformance as it relates to the product and processes.   Lead management review for the site.   Lead and manage audit readiness