Senior Software QA Engineer – Remote Postmarket

Dexcom, Inc

Sacramento (CA)

On-site

USD 96,000 - 160,000

Full time

14 days+
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Benefits offered by this job

Comprehensive benefits
Growth opportunities
Tuition reimbursement
Career development

Job summary

Dexcom, a leader in continuous glucose monitoring, seeks a Software Quality Engineer focused on postmarket issues to safeguard patient safety and product reliability. You will partner with Regulatory, Quality, R&D and Process Engineering to investigate software- and device-related postmarket issues.

You will apply structured problem solving, lead studies, and communicate findings to technical and non-technical stakeholders.

Qualifications

  • Bachelor’s degree in a technical discipline; 5–8 years related experience.
  • Experience with software quality engineering across the product lifecycle.
  • Knowledge of FDA 21 CFR Part 820, IEC 62304, ISO 13485, ISO 14971.
  • Strong communication and cross-functional collaboration skills.

Responsibilities

  • Collaborate with Regulatory Affairs, Quality, R&D, and Process Engineering to investigate postmarket issues.
  • Lead development and improvement of complaint investigation processes.
  • Evaluate product performance using software risk management analyses.
  • Apply structured problem-solving to identify root causes.
  • Communicate outcomes to stakeholders and support decision-making.

Skills

Software quality
Regulatory compliance
Software risk management
Data analysis
Cross-functional collaboration
Problem solving

Education

Bachelor's degree in technical discipline

Tools

DFMEA
PFMEA
Statistical analysis

Job description

Dexcom, a leader in continuous glucose monitoring, seeks a Software Quality Engineer focused on postmarket issues to safeguard patient safety and product reliability. You will partner with Regulatory, Quality, R&D and Process Engineering to investigate software- and device-related postmarket issues.

You will apply structured problem solving, lead studies, and communicate findings to technical and non-technical stakeholders.

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