QA Engineer 1

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.

Summary:

Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.

Essential Duties and Responsibilities:

• Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products.

• Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution.
• Review, assess, and process Nonconforming Material Reports (NCMRs) for completeness, accuracy, and compliance with internal procedures.
• Verify defect descriptions, quantities, affected lots/batches, containment actions, and supporting evidence before disposition.
• Coordinate disposition decisions such as Use-As-Is, Rework, Return to Vendor, or Scrap with relevant stakeholders.
• Ensure all disposition decisions are technically sound, well-documented, and aligned with quality and regulatory requirements.
• Support daily Material Review Board (MRB) activities by managing assigned NCMRs from initiation to closure.
• Follow up with responsible functions to ensure timely review, disposition, and closure of open cases.
• Escalate aging or overdue NCMRs to the appropriate team or management for action.
• Maintain good control of MRB workflow to avoid backlog and prevent delays to production or shipment.
• Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary.
• Monitor and track NCMR data trends to support timely decision-making and improve visibility of nonconformance issues.
• Maintain and analyze key MRB/NCMR metrics, such as:

Number of open NCMRs Aging status of NCMRs Disposition turnaround time Scrap quantity and cost Rework trends Repeat defect occurrence Defect category by product, process, supplier, or area.

• Generate regular reports, dashboards, or summaries to highlight:

Top contributors to NCMR generation Recurring defect patterns High-risk issues requiring escalation Opportunities for quality improvement

• Perform basic data analysis to identify trends, gaps, and priority areas for corrective action.
• Support preparation of MRB performance review materials for management discussion.
• May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO Six Sigma).
• Support the development of systems and perform quality functions that help Dexcom achieve its quality policy and compliance with domestic and international regulations.  Some examples include Auditing, Calibrations, CAPA, Customer complaint processing, Document control, Nonconforming materials, Process controls, Receiving inspection, Training.
• Support the internal audits to ensure systems comply with requirements and are effective.
• Support risk management, validation, sample size, and external standards review and implementation activities.
• Employs techniques like six sigma, lean manufacturing to improve Dexcom operations.
• Improves systems and processes that improve product safety; increase product consistency and conformance to requirements; improve production efficiency; reduce operating and scrap costs.
• Coordinates the disposition of nonconforming materials with the Materials Review Board.

• Applies proficient computer skills in the use of Microsoft Office and database applications (e.g. Excel and Power BI).
• Assumes and performs other duties as assigned.

Experience and Education Requirements:

Bachelor’s degree and typically 0-2 years of related experience; or equivalent combination of education and experience. Medical Device experience preferred.

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.