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 by unlocking information and insights that drive better health outcomes. Today we are broadening our vision beyond diabetes to empower people to take control of their health with personalized, actionable insights that solve important health challenges. We are committed to improving human health and to becoming a leading consumer health technology company through unique biosensing‑technology experiences.Quality Compliance Specialist IIThe Quality Compliance Specialist II supports the start‑up of our first European manufacturing site in Athenry. The role ensures compliance with applicable government regulations, industry standards, and internal policies and procedures. It performs evaluation of internal operations, product/process controls, communications, risk assessments, and maintenance of documentation related to quality and regulatory compliance. The specialist recommends and supports appropriate changes at a site or global level, supports internal and external audits, coordinates regulatory submissions, and maintains the Dexcom QMS.ResponsibilitiesSupport Quality and Compliance Activities: Oversees the quality and compliance aspects of establishing and maintaining processes related to commercial product shipment and release from Dexcom Ireland and global distribution centres.Maintain and support Quality Plans to ensure Dexcom’s medical devices meet regulatory, customer, and internal quality requirements throughout the product lifecycle.Own and manage change orders impacting the Quality Management System (QMS) and facilitate cross‑functional collaboration across departments and sites to ensure changes are thoroughly assessed and effectively implemented.Lead and support Corrective and Preventive Action (CAPA) investigations and drive process improvement initiatives related to the QMS, ensuring timely resolution and effectiveness verification.Assess changes to QMS documentation, ensuring compliance with applicable standards and regulations.Lead or support the integration of new regulations or QMS standards by conducting gap assessments, recommending updates, and driving documentation revisions.Lead or support ongoing improvement and maintenance of the QMS to enhance operational efficiency, compliance, and product quality.Conduct internal audits and support external inspections by regulatory bodies and notified parties, ensuring audit findings are addressed and closed effectively and preparing quality system documentation and records for audits and inspections.Lead or support compliance‑related training initiatives within the Quality Department, ensuring personnel are trained to meet regulatory, GMP, and internal quality standards.Define, monitor, and report on key quality metrics and performance indicators (e.g., CAPA closure rates, deviation trends, audit findings) as part of Management Review and internal metric review meetings.Perform other duties as assigned, reflecting management’s assignment of essential functions and allowing additional responsibilities to be delegated.QualificationsExperience with Quality Management Systems, Audits, CAPA, Change Management, and Management Review.Knowledgeable in ISO 13485:2016, CFR Part 820, ISO 14971, CMDR, and other regulations applicable to medical devices.Collaborative, able to work effectively with diverse functional groups, multitask, and adapt to changing priorities.Demonstrates diligence, technical competence, and good judgement associated with each essential duty and responsibility.Experience and Education RequirementsTypically requires a Bachelor’s degree and a minimum of 2–5 years of related experience, or a Master’s degree with 2–5 years of equivalent industry experience.BenefitsA front‑row seat to life‑changing CGM technology.A comprehensive benefits program.Growth opportunities on a global scale.Access to career development through in‑house learning programs and/or qualified tuition reimbursement.An innovative, industry‑leading organization committed to employees, customers, and the communities we serve.
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