Senior Software QA Engineer — Medical Device Compliance

Regulatory Jobs; United States; Remote; USD 79.000 - 132.000; Vollzeit

Zusammenfassung

Dexcom Corporation seeks a Software Quality Assurance Engineer to support regulatory compliance and software validation across cross-functional teams. You will guide IEC 62304, 21 CFR 820, ISO 14971 and other regulations, drive risk management deliverables, and review technical documentation.

This role partners with Software Design and Test, supports post-market activities, communicates plans and status to management in a fast-paced environment, and requires a technical bachelor’s with 2–5 years

Qualifikationen

• Experience with software mobile applications is required.
• Regulatory compliance experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485 and ISO 14971 is preferred.
• Strong SDLC knowledge and methodologies (Agile/Waterfall).

Aufgaben

• Participate as a core team member of the R&D Quality Assurance Engineering team.
• Provide guidance on IEC 62304, 21 CFR 820, ISO 14971 and related regulations worldwide to cross-functional teams.
• Lead in the application, compliance and improvement of policies, procedures and practices for software development and validation across software teams.
• Provide technical guidance on equipment, software, product, process requirements and risk management deliverables (SHA, FMEA).
• Guide Software Design and Test Teams for system validations, design verification, traceability, CM, tool validations and integrations.
• Support post-market activities related to software anomalies, risk assessments and CAPA.
• Review, author, revise and approve technical documentation (DHF, SOPs, protocols, reports).
• Assess impact of change control to maintain compliance.
• Communicate with Dexcom team and upper management on plans and progress.

Kenntnisse

Mobile software

Software QA

Requirements analysis

Product integration

Software testing

Cyber security

CSQE certification

Jama

Jira

TestRail

Ausbildung

Bachelor's degree in a technical discipline

Master's degree (optional)

Tools

Jama

Jira

TestRail

Kettryx

Jobbeschreibung

Dexcom Corporation seeks a Software Quality Assurance Engineer to support regulatory compliance and software validation across cross-functional teams. You will guide IEC 62304, 21 CFR 820, ISO 14971 and other regulations, drive risk management deliverables, and review technical documentation.

This role partners with Software Design and Test, supports post-market activities, communicates plans and status to management in a fast-paced environment, and requires a technical bachelor’s with 2–5 years