Staff QA Engineer
Core
Define requirements and develop analytic dashboards for Manufacturing Controls, Quality Management Systems, and New Product Development; coordinate audits and non-conforming events.
Role type
Staff Quality Assurance Engineer (Medical Devices)
Builds
Quality Assurance Metric Dashboards, Non-Conforming Events (NCE) system
Domain
Medical Devices / Continuous Glucose Monitoring / Quality Engineering
Deliverable
dashboards & analysis (via careerplan.io/jobs/JR119794-staff-qa-engineer-at-dexcom)
Required skills
Quality Management Systems (QMS), Non-Conforming Material handling, CAPA, Internal and External Audits, FDA audit experience, Dashboard development (Power BI, Tableau), Statistical analysis (Minitab, JMP), Risk management, Validation (Equipment, Process, Software, Test Method), Document control, Inspection criteria application
Preferred skills
Certified Quality Engineer (CQE), Certified Quality Auditor (CQA)
Technologies
Power BI, Tableau, Oracle, Camstar, IQVIA, 1Factory, EtQ Reliance, SQL Servers, Google Big Query, Minitab, JMP
Responsibilities
Lead design, development, validation, and deployment of QA Metric Dashboards; Coordinate Non-Conforming Events (NCE) system; Administer specific aspects of the quality system; Design and apply company policies for regulatory compliance; Participate in internal and external audits; Participate in design teams representing QA; Apply risk management and validation activities; Coordinate disposition of nonconforming materials.
Seniority
Staff, hands-on IC with strategic coordination