Senior QA Manager (Quality Systems)
DexComThe 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.
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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:ย
Are youย seekingย toย demonstrateย yourย expertiseย toย giveย something significant andย assistย 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!ย
Our Quality Assurance team are looking for the right teammate to support our European manufacturing site in Athenry.ย Asย Seniorย QA Manager, you will manage the development and implementation of the organizationโs quality policies and programs.ย You will alsoย be responsible forย ensuring systemsย comply withย FDA and ISO quality system regulations.ย
Where you comeย in:ย ย
Theย Seniorย QA Manager provides support for the projects, functions, and strategicย objectivesย of Quality System Compliance (Audit/CAPA/NCMR/Internal Audit/Management Review) and the document control area.ย
You are a strong tactical decision-maker,ย handlesย unforeseen issues as they relate to Dexcomโs compliance with regulations and conformance to required regulations.ย
You regularly interact with senior management or executiveย levels on mattersย regarding Dexcomโs compliance with regulations and conformance to required regulations.ย
Youย are responsible forย theย areaย operational management withย a track recordย of working/supporting high volume manufacturing.ย
You design andย maintainย the quality system according to written policies and procedures.ย
You understand domestic and international Quality System Requirements and how they interact to be able toย provideย quality guidance to other departments and companies. Must have the ability to change the thinking of, or gain acceptanceย from,ย others in sensitive situations, without damage to the relationship.ย
Youย establishย operationalย objectivesย and work plans for the Quality Department and delegates assignments. Specifically, assuring your team are meeting sustaining &ย development project deliverables, creating communication between cross-functional departments,ย participatingย in process or product investigations,ย identifyingย potential rootย causesย and providing business solutions.โฏYou exercise supervision in terms of costs, methods, and staffing.ย
You lead the team that manages projects and non-conformance as it relates to the product and processes.ย
Lead management review for the site.ย
Lead and manage audit readiness for the site.
What makes you successful:ย ย
You bring experience in MDSAP/ISO13485/FDA21CFR820(QMSR).
You have managed Back/Front rooms in external/internal audits.
You review data on product defects, product response plans and product dispositions; recommend and implement improvements.ย
You have knowledge of techniques like six sigma, lean manufacturing, samplingย plansย and other statistical modelling.ย
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.ย
Experience & Education:
Typically requires a bachelor's degree in a technical discipline with 13+ years of industry experience and 5โ8 years of previous people management experience.
What youโll get:
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:
5-15%
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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.
AI in Hiring Notice:ย Weย mayย use AI supported toolsย to help make our hiring process more efficient, consistent, and accessible for candidates around the world.ย All hiring decisions are made by people.
At Dexcom, we are committed to providing a fair and inclusive recruitment process, and welcome candidates of all genders and gender identities to apply. If any wording in this description appears unintentionally gendered or exclusionary, please be assured this is not intentional.
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Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at talentacquisition@dexcom.com.
The annualised base salary for this position is from โฌ108,715.00 to โฌ140,690.00 gross. Final offer will depend on your qualifications, competencies, and professional experience.
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