Senior Quality Engineer – Medical Devices (On-site)

Regulatory Jobs; California; On-site; USD 110,000 - 121,000; Full time

Job summary

Tandem Diabetes Care is seeking a Senior Quality Engineer to lead sustaining engineering, production, and quality system activities in a FDA-regulated hardware development environment. You will review changes, ensure regulatory documentation, and drive CAPA and risk management to protect patient safety and product quality.

The role requires 5+ years in quality engineering with expertise in sterilization, cleanroom standards, and regulatory standards including ISO 13485 and FDA QMSR.

Qualifications

• Bachelor's degree in a technical field; Mechanical Engineering preferred.
• 5+ years of Quality Engineering experience in FDA-regulated hardware development or medical device environments.
• Knowledge of ISO 13485, FDA QMSR, ISO 14971.
• Experience with sterilization, endotoxin testing, and cleanroom standards (ISO 11137, ISO 14644).
• Proficiency with statistical methods (SPC) and problem-solving methodologies; ability to lead CAPA.
• Familiarity with GD&T and engineering drawings; ability to interpret specifications.

Responsibilities

• Serve as Quality lead on sustaining engineering, production, and quality system activities.
• Review and approve product/process changes to ensure design controls, verification, validation, and documentation per regulations.
• Investigate quality issues, perform risk assessment, and drive corrective and preventive actions (CAPA).
• Lead sterilization validation activities and monitor bioburden data; ensure continued state of control.
• Collaborate with Manufacturing, Facilities, Microbiology, Validation, and Regulatory Affairs to maintain cleanroom effectiveness.
• Monitor environmental monitoring data and drive improvements to meet ISO/regulatory requirements.
• Prepare and review COs, non-conformances, and documentation for regulatory compliance.

Skills

Quality Engineering

Regulatory compliance

Sterilization knowledge

Cleanroom standards

Statistical techniques

Problem solving

GD&T

MS Office

MiniTab

Education

Bachelor's degree in a technical field

Tools

MiniTab

MS Office

Job description

Tandem Diabetes Care is seeking a Senior Quality Engineer to lead sustaining engineering, production, and quality system activities in a FDA-regulated hardware development environment. You will review changes, ensure regulatory documentation, and drive CAPA and risk management to protect patient safety and product quality.

The role requires 5+ years in quality engineering with expertise in sterilization, cleanroom standards, and regulatory standards including ISO 13485 and FDA QMSR.