Remote Software QA Engineer – Medical Device Quality

RXinsider LTD.; San Diego (CA); On-site; USD 62,000 - 103,000; Full time

Benefits offered by this job

Benefits program

Career development

Tuition reimbursement

Global opportunities

Job summary

Dexcom Corporation is seeking a Software Design Assurance Engineer in the San Diego area to support software safety and quality compliance across design, development, and validation activities.

You will collaborate with cross-functional teams to ensure conformance to IEC 62304, FDA 21 CFR Part 820, ISO 13485, and ISO 14971, drive risk management, review design control artifacts, and support post-market activities. Remote work allowed with occasional onsite visits.

Qualifications

• Bachelor's degree in a technical discipline
• 0-2 years of related experience
• Experience with FDA 21 CFR Part 820, IEC 62304, ISO 13485 would be a plus

Responsibilities

• Actively participates as a core team member of the R&D Quality Assurance Engineering team.
• Provide guidance on IEC 62304, 21 CFR 820, and other relevant regulations worldwide
• Lead in the effective application, compliance, and continuous improvement of software development and validation policies across software teams
• Drive pre-market risk management deliverables like SHA, design FMEA and support cybersecurity risk management
• Review and approves all software design control deliverables
• Support post-market activities related to software anomalies, risk assessments and CAPA
• Lead and support R&D SW Design Assurance efforts including continuous improvement opportunities
• Review, author, and revise design history files, SOPs, protocols and reports

Skills

FDA 21 CFR 820

IEC 62304

ISO 13485

SDLC

Agile

Software Quality

Cloud

Education

Bachelor's degree in technical discipline

Tools

Cloud platforms

Job description

Dexcom Corporation is seeking a Software Design Assurance Engineer in the San Diego area to support software safety and quality compliance across design, development, and validation activities.

You will collaborate with cross-functional teams to ensure conformance to IEC 62304, FDA 21 CFR Part 820, ISO 13485, and ISO 14971, drive risk management, review design control artifacts, and support post-market activities. Remote work allowed with occasional onsite visits.