Quality Assurance Manager

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 are looking for the right teammate to support the start-up of our first European manufacturing site in Athenry. As a Quality Assurance 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 Quality Assurance Manager provides support for the projects, functions, and strategic objectives of the Incoming Inspection, Lot Release, Compliance and document control and training areas. 

• You are a strong tactical decision-maker, handles unforeseen issues as they relate to Dexcom’s compliance with regulations and each supplier’s conformance to required regulations. 

• You regularly interact with senior management or executive levels on matters regarding Dexcom’s compliance with regulations and each supplier’s conformance to required regulations. 

• You exercise supervision in terms of costs, methods, and staffing. 

• 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 sustaining and research and development project deliverables, creating communication between cross-functional departments, participating in process or product investigations, identifying potential root causes and providing business solutions.  

• You utilize quality feedback data from customers, consumers and internal inputs to drive continual improvement activities needed to achieve department strategic goals. 

• Lead the team that manages projects and non-conformance as it relates to the product and processes. 

What makes you successful:  

• You review data on product defects, product response plans and product dispositions; recommends and implements improvements. 

• You have knowledge of techniques like six sigma, lean manufacturing, sampling plans and other statistical modelling. 

• You take the initiative to develop systems and processes that: improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs. 

What you’ll get: (this section should not be modified) 

• A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. 

• 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: (Highlight the appropriate range) 

• 10-15%