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.