Quality Assurance Manager

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 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 Quality Assurance Manager, you will provide technical support for the projects, functions, and strategic objectives of quality. You will also be responsible for various aspects of Quality Engineering, including the supervision of support personnel and/or administration of specific aspects of the quality system.   

Where You Come In:

• You will develop, implement and maintain technical quality assurance and control systems 
• You will define and specify the implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, and reliability of company products  
• You will review engineering designs and contribute quality requirements and considerations  
• You will assist the product support areas in gathering and analysing data  
• You will supervise team in terms of costs, methods, and staffing  
• You will establish operational objectives and work plans for the Quality Department and delegates assignments. Specifically, assuring team are meeting sustaining project deliverables, creating communication between cross-functional departments, participating in the process or product investigations, identifying potential root causes, and providing business solutions  
• You will be responsible for ensuring the Quality Management System requirements are established and maintained at site and the internal policies, customer expectations, and regulatory requirements are met  
• You will support complex, cross-functional quality issues in a variety of subject matter areas and drives resolution and proactive solutions to customer complaints  

What Makes You Successful:

• Typically requires a Bachelor’s degree with 8-12 years of industry experience
• 2-5 years of previous management or lead experience
• You have medical device industry experience  
• You have knowledge and understanding of the Food and Drug Administration (FDA) 21 CFR 820 and International Organization for Standardization (ISO 13485 Quality management systems)
• Audit front room experience an advantage
• You have technical writing skills as applied to manufacturing documentation and process development – you are experienced in creating and revising technical documentation  
• You have hands-on experience with high-volume manufacturing and equipment development for assembly and automation systems.  

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.

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.