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Quality Systems & Operations Manager, Athenry
Client: Dexcom
Location: Athenry, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference: ac16e62ff5c8
Job Views: 15
Posted: 21.01.2025
Expiry Date: 07.03.2025
Job Description:
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.
Are you seeking to demonstrate your expertise to give to 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 is looking for the right teammate to support the start-up of our first European manufacturing site in Athenry. As a Quality Systems/Operations 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 Systems/Operations Manager provides support for the projects, functions, and strategic objectives of the Incoming (Receiving) Inspection, Product Release, Quality System Compliance (Audit/CAPA/NCMR) and the document control/training areas.
* You are a strong tactical decision-maker, handling unforeseen issues as they relate to Dexcom’s compliance with regulations.
* You regularly interact with senior management or executive levels on matters regarding Dexcom’s compliance with regulations.
* You exercise supervision in terms of costs, methods, and staffing.
* 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 provide quality guidance to other departments and companies.
* You establish operational objectives and work plans for the Quality Department and delegate assignments, assuring your team meets project deliverables.
* You utilize quality feedback data from customers 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.
* Lead management review for the site.
What makes you successful:
* You review data on product defects, response plans and dispositions; recommend and implement 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, consistency, conformance to requirements, production efficiency, and reduce costs.
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.
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