Senior Quality Engineer – Medical Devices (Onsite)

Regulatory Jobs; San Diego (CA); On-site; USD 110,000 - 121,000; Full time

Job summary

Tandem Diabetes Care seeks a Senior Quality Engineer to lead quality activities across sustaining engineering, production, and regulatory-compliant processes. You will review changes, approve designs, and drive risk management and continuous improvement to ensure device quality and patient safety.

Ideal candidates have 5+ years in FDA-regulated hardware or medical device development, are proficient in ISO 13485 and ISO 14971, and excel with data analysis and MCP tools.

Qualifications

• 5+ years experience in FDA-regulated hardware development or medical device development.
• Demonstrates proficient knowledge of Quality Engineering policies and practices.
• Proficient knowledge of quality standards (ISO 13485, FDA QMSR, ISO 14971).
• Proficiency with querying, navigating, and analyzing datasets.

Responsibilities

• Serve as a Quality lead on sustaining engineering, production, and quality system activities.
• Review and approve product and process changes/new designs for compliance and verification.
• Lead risk management activities and drive improvements in quality systems.

Skills

Quality engineering

Statistical methods

Problem solving

GD&T

MS Office

MiniTAB

Education

Bachelor's degree

Tools

MiniTab

MS Office

Job description

Tandem Diabetes Care seeks a Senior Quality Engineer to lead quality activities across sustaining engineering, production, and regulatory-compliant processes. You will review changes, approve designs, and drive risk management and continuous improvement to ensure device quality and patient safety.

Ideal candidates have 5+ years in FDA-regulated hardware or medical device development, are proficient in ISO 13485 and ISO 14971, and excel with data analysis and MCP tools.