Senior Quality Engineer - Medical Devices (On-Site)

Tandem Diabetes Care Inc.; California; On-site; USD 120,000 - 170,000; Full time

Job summary

Tandem Diabetes Care Inc. seeks a Senior Quality Engineer to provide quality guidance across product launches, sustaining engineering, and quality systems in a manufacturing environment.

You will optimize internal operations, ensure conformance to specifications, and drive risk reduction throughout the hardware development lifecycle. As a quality lead, you’ll review design changes for regulatory compliance, analyze quality data, lead audits, and support CAPA investigations, NCRs, and Gage R&R,

Qualifications

• Bachelor’s degree in a technical field or equivalent work experience.
• 5+ years as a Quality Engineer in FDA-regulated hardware/medical device development.
• Solid knowledge of QMS standards: ISO 13485, FDA QMSR, ISO 14971.
• Experience querying, navigating and analyzing datasets with test/quality equipment.
• Strong statistics skills: sampling, capability analysis, SPC.
• Experience generating/analyzing quality metrics.
• Familiarity with problem-solving methods (why-why, fault tree, cause-and-effect).
• Ability to work independently to identify issues and propose fixes.
• GD&T understanding of mechanical drawings and specifications.

Responsibilities

• Lead sustaining engineering, production, and quality system activities as quality lead.
• Review/approve product and process changes ensuring V&V per regulatory requirements.
• Identify quality risks, drive actions to optimize quality and cost efficiency.
• Analyze quality problems in products and processes and implement improvements.
• Support IQ/OQ/PQ development for processes and equipment.
• Manage NCRs and monitor closures; review COs and provide quality input.
• Contribute to supplier and process improvement initiatives.

Skills

Quality engineering

Statistical methods

Problem solving

Independent work

GD&T

Quality metrics

Data analysis

A

Education

Bachelor’s degree in a technical field

Job description

Tandem Diabetes Care Inc. seeks a Senior Quality Engineer to provide quality guidance across product launches, sustaining engineering, and quality systems in a manufacturing environment.

You will optimize internal operations, ensure conformance to specifications, and drive risk reduction throughout the hardware development lifecycle. As a quality lead, you’ll review design changes for regulatory compliance, analyze quality data, lead audits, and support CAPA investigations, NCRs, and Gage R&R,