Senior Postmarket Investigation & Quality Engineer

Dexcom Inc.

San Diego (CA)

On-site

USD 96,000 - 160,000

Full time

14 days+

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Benefits offered by this job

Benefits program
Career development
Tuition reimbursement
Growth opportunities

Job summary

Dexcom Inc. is seeking a senior postmarket investigations specialist to join the Customer Advocacy organization.

You will collaborate across Regulatory Affairs, Quality, R&D, Clinical, and Process Engineering to resolve software- and device-related postmarket issues, and to improve complaint investigation processes with risk management alignment. You will analyze data to identify root causes, communicate findings to stakeholders, and drive CAPA and other quality activities to enhance product

Qualifications

  • Bachelor’s degree in a technical discipline is required.
  • Experience in medical device quality systems and regulatory requirements is preferred.
  • Strong knowledge of software risk management and postmarket surveillance.
  • Ability to communicate complex technical concepts to diverse stakeholders.

Responsibilities

  • Collaborate with Regulatory Affairs, Quality, R&D, Clinical, and Process Engineering to investigate postmarket issues.
  • Develop and improve complaint investigation processes aligned with risk management activities.
  • Understand Dexcom’s software ecosystem to evaluate performance and identify improvements.
  • Apply structured problem-solving and data-driven approaches to investigations and root-cause analysis.
  • Communicate outcomes to technical and non-technical stakeholders with clear recommendations.
  • Contribute to CAPA, HHEs, and other quality system activities for postmarket issues.

Skills

Regulatory knowledge
Software quality
Risk management
Data analysis
Communication
Problem solving
Cross-functional teamwork
Analytics mindset

Education

Bachelor’s degree in technical discipline

Tools

DFMEA
PFMEA
Statistical analysis

Job description

Dexcom Inc. is seeking a senior postmarket investigations specialist to join the Customer Advocacy organization.

You will collaborate across Regulatory Affairs, Quality, R&D, Clinical, and Process Engineering to resolve software- and device-related postmarket issues, and to improve complaint investigation processes with risk management alignment. You will analyze data to identify root causes, communicate findings to stakeholders, and drive CAPA and other quality activities to enhance product

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