Dexcom Corporation – Software QA Engineer
Job Description
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.
This functional department provides technical support and guidance to Software teams to ensure conformance to software development process and other applicable safety and quality system regulation and standards (e.g. IEC 62304, ISO 13485, ISO 14971). We are responsible for various aspects of Software Design Assurance with focus on product improvement, new product development and defect prevention. We interface with different cross functional groups (Software Engineering, Software Test, Regulatory Affairs, Marketing, Project managers, Systems Engineering and others). This team has a great team culture supporting each other in a fast-paced environment and dealing with shifting priorities with a positive attitude. This is not a test role
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Responsibilities
You will actively participate as a core team member of the R&D Quality Assurance Engineering team.
You will provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide to the cross-functional teams.
You will lead in the effective application, compliance, and continuous improvement of policies, procedures, and practices related to software development and validation across software teams.
You will provide technical guidance with respect to equipment, software, product, process requirements and driving risk management deliverables like SHA, design and process FMEA.
You will provide guidance to Software Design and Test Teams for System validations, Software design verification and traceability, Software configuration management, tool validations and software integrations.
You will support post market activities related to Software anomalies, risk assessments and CAPA activities (if applicable)
You are responsible for reviewing, authoring, revising, and approving appropriate technical documentation including design history file, standard operating procedures, protocols, reports, and software design control deliverables.
You will assess impact of change control to ensure no adverse impact to product performance and a state of compliance is maintained.
You will effectively communicate with broad Dexcom team and upper-level management on plans, status of tasks, project progress and challenges.
You will assume and perform other duties as assigned.
