QA Engineer Digital Systems

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. Meet the team: As a QA Engineer, you will play an integral role in ensuring the quality of site processes and digital manufacturing to Dexcom standards. This crucial position supports Dexcom's exciting growth trajectory in delivering essential, life-changing products to our customers. As part of this dynamic and highly effective team, you will work closely across multiple functions, gaining broad exposure to our entire product life cycle. Where you come in: You will have experience in compliance and validation of manufacturing and digital systems exposure. You will contribute to the development and use of standardized validation templates and practices, while support validation activities for digital manufacturing systems, including MES. You will apply risk-based validation principles to system implementation and changes for digital manufacturing systems. You will be involved in planning, managing and prioritizing tasks/projects, tracking progress towards the overall goals and provide periodic updates to management. You will be responsible for OOS events, CAPAs, NCMRs and Change Order; establishing and maintaining communication to key stakeholders, reporting, investigation, disposition and the corrective action process. You will support the integration of new regulations or QMS standards by conducting gap assessments, recommending updates, and driving documentation revisions. You will support ongoing improvement and maintenance of the QMS to enhance operational efficiency, compliance, and product quality. You will support external inspections by regulatory bodies and notified parties. Ensure audit findings are addressed and closed effectively. Prepare quality system documentation and records for internal and external audits/ inspections. You may perform other duties as assigned. What makes you successful: You have experience with CAPA, Non-Conformance, and problem-solving tools. You have experience working in digital systems is preferred You have experience participating in continuous improvement initiatives. You have proficiency in Microsoft Office and database applications (e.g., Excel and MiniTab or similar). You have strong critical thinking, decision-making, and problem-solving skills. You posses excellent written and oral communication and presentation skills. Experience and Education Requirements: Typically requires a Bachelor’s degree in a technical discipline and 2–5 years of related experience, or a Master’s degree and 0–2 years of equivalent experience. You have experience in Quality in a medical device or related industry manufacturing environment. What you’ll 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 . 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. #DexcomIreland