Senior Quality Engineer: Medical Devices (Onsite)

Tandem Diabetes; California; On-site; USD 110,000 - 170,000; Full time

Job summary

Tandem Diabetes Care is hiring a Senior Quality Engineer to lead sustaining engineering, quality systems, and process improvements for our hardware development programs. This role will ensure product and process changes meet regulatory requirements while driving risk reduction and quality excellence across the organization.

You will support audits, NCRs, CAPAs, and cross-functional teams; work on-site five days a week at the Barnes Canyon office, adhering to Privacy/HIPAA and safety standards.

Qualifications

• Bachelor’s degree in a technical field, preferably Mechanical Engineering
• 5+ years experience as a Quality Engineer in an FDA-regulated hardware development environment, medical device development, or FDA-regulated industry.
• Proficient knowledge of Quality Engineering policies and best practices.
• Proficient knowledge of ISO 13485, FDA QMSR, ISO 14971.
• Proficiency with querying, analyzing datasets and quality measurement equipment.
• Strong statistics including sampling theory, probability, capability analysis, and SPC.
• Experience using problem solving methodologies (why-why, fault tree, cause-effect).
• Ability to work independently to identify issues and propose solutions.
• Understanding of GD&T and mechanical drawings.

Responsibilities

• Lead sustaining engineering, production, and quality system activities.
• Review and approve product and process changes/new designs per regulatory requirements.
• Analyze and solve quality problems with products and processes.
• Provide input to IQ/OQ/PQ development for processes and equipment.
• Support NCR process and monitor closures; ensure timely resolution.
• Lead cross-functional process improvement teams to drive quality and cost savings.
• Ensure training completion before assuming responsibilities.
• Ensure compliance with Privacy/HIPAA, safety, and company policies.

Skills

Quality engineering

Statistical analysis

Problem solving

Independent worker

Data analysis

Quality metrics

GD&T understanding

Communication

Education

Bachelor’s degree in a technical field

Tools

IQ/OQ/PQ development

Gage R&R

Design of Experiments (DoE)

V&V testing

Job description

Tandem Diabetes Care is hiring a Senior Quality Engineer to lead sustaining engineering, quality systems, and process improvements for our hardware development programs. This role will ensure product and process changes meet regulatory requirements while driving risk reduction and quality excellence across the organization.

You will support audits, NCRs, CAPAs, and cross-functional teams; work on-site five days a week at the Barnes Canyon office, adhering to Privacy/HIPAA and safety standards.