Where you come in
Serve as the Subject Matter Expert (SME) for validation and compliance of Enterprise and Manufacturing Systems, including MES/Camstar, ERP, QMS, SCADA, PLC, Data Historians, EBR, and other GxP-regulated platforms.
Lead verification and validation activities, including Computer System Validation (CSV), Computer Software Assurance (CSA), Process Validation (IQ/OQ/PQ/PPQ), Test Method Validation, and Validation Master Planning.
Provide QA and QC requirements, guidance, and oversight for IT and Operational Technology (OT) systems while ensuring regulatory compliance and inspection readiness.
Perform GxP risk assessments at the system, functionality, and data-element levels, applying risk management principles, sample size determination, and external standards review.
Serve as a core advisor to IT, OT, Quality, Manufacturing, and cross-functional teams by providing expertise on validation strategies, quality systems, compliance requirements, and risk mitigation.
Ensure compliance with FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485, EU MDR, and other applicable domestic and international regulations.
Develop, execute, and maintain validation deliverables throughout the SDLC, including Validation Plans, Protocols, Risk Assessments, Traceability Matrices, Test Scripts, and Summary Reports.
Effectively communicate project progress, validation status, compliance risks, and key challenges to broad Dexcom teams and senior leadership.
Independently lead validation initiatives and project activities across cross-functional teams and projects of varying complexity.
Design and continuously improve policies, procedures, and quality systems supporting validation, auditing, CAPA, calibration, training, document control, customer complaints, nonconforming materials, receiving inspection, and process controls.
Apply Six Sigma, Total Quality Management (TQM), and continuous improvement methodologies to improve product safety, product consistency, compliance, operational efficiency, and cost performance.
Interpret specifications and inspection criteria while utilizing Microsoft Office, Excel, MiniTab, and database applications to support quality, compliance, and business objectives.
Perform additional duties and responsibilities as assigned in support of business and quality objectives.
What makes you successful
Bachelor's degree in Engineering, Quality, Computer Science, Life Sciences, or a related discipline.
Minimum of 5 years of direct experience validating manufacturing systems and regulated computer systems within medical device, pharmaceutical, or other highly regulated industries.
Proven experience validating enterprise systems such as MES, ERP, QMS, EDMS, Clinical Data Management Systems, LIMS, and manufacturing automation solutions including PLC, SCADA, Data Historians, and EBR.
Strong understanding of GxP business processes, Quality Management Systems, FDA electronic records and electronic signature requirements, and computerized system validation expectations.
Demonstrated expertise in FDA Computer Software Assurance (CSA), risk-based validation methodologies, and Computer System Validation (CSV) principles.
Comprehensive knowledge of FDA 21 CFR Part 11, FDA 21 CFR 820, ISO 13485, EU MDR, and related regulatory requirements.
Proven experience delivering full lifecycle CSV programs and maintaining compliance across both IT and OT environments, including 21 CFR Part 11 impacted systems.
Hands-on experience creating and executing Validation Plans, Protocols, Risk Assessments, Traceability Matrices, Test Scripts, and other validation documentation across all phases of the SDLC.
Ability to independently manage projects, prioritize competing demands, and successfully lead cross-functional teams and stakeholders.
Proven organizational skills and collaboration skills, with experience influencing teams and driving alignment across business and technical organizations.
Excellent written and verbal communication skills, strong organizational and analytical capabilities, and exceptional attention to detail.
ASQ Software Quality Engineer (SQE) certification, Medical Device industry experience, expertise in 21 CFR Part 11, and familiarity with 21 CFR 820 are highly desirable.
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Should a reasonable accommodation be necessary to aid a disability, requests should be sent to Dexcom Talent Acquisition at talentacquisition@dexcom.com.
