QA Engineer 2 - Software Systems
Core
Ensuring compliance of computerised systems, electronic records, and manufacturing software applications with regulatory requirements to support Dexcom's quality and manufacturing operations.
Role type
Quality Engineer II (Software Systems)
Builds
Validated software systems for medical device manufacturing and quality operations
Domain
Medical Devices / Regulated Manufacturing / Quality Assurance
Deliverable
client delivery
Required skills
Computerized System Validation (CSV), 21 CFR Part 11 compliance, Data Integrity principles, Risk Assessment, Audit Trail Review, Change Control management, CAPA activities, SQL (read-only queries), Regulatory Standards interpretation
Preferred skills
ISO 13485 knowledge, MES/ERP/QMS application experience, FDA/BSI/MDSAP audit experience, Mentoring
Technologies
MES, ERP, QMS applications, SQL
Responsibilities
Review and approve software validation deliverables (Plans, URS, Protocols, Reports), Ensure robust software validation practices across departments, Support software-related nonconformance events and investigations, Perform periodic reviews of computerized systems for compliance, Support internal and external regulatory audits, Provide guidance on software lifecycle processes and data integrity initiatives
Seniority
Mid-level, hands-on IC
