Senior Quality Engineer, Medical Device Manufacturing

Tandem Diabetes Care Inc.; California (MO); On-site; USD 110,000 - 121,000; Full time

Job summary

Tandem Diabetes Care Inc. is seeking a Senior Quality Engineer to lead quality activities in sustaining engineering and manufacturing at our Barnes Canyon site.

You will oversee product and process changes, drive quality improvements, and support sterilization validation, environmental monitoring, and CAPA investigations. Candidates should have 5+ years in quality engineering for FDA-regulated hardware and strong knowledge of ISO 13485, FDA QMSR, and ISO 14971.

Qualifications

• Bachelor’s degree in a technical field or equivalent experience.
• 5+ years’ experience as a Quality Engineer in FDA-regulated hardware or medical device development.
• Proficient knowledge of ISO 13485, FDA QMSR, ISO 14971.
• Experience with sterilization, endotoxin testing, and cleanroom standards.
• Strong statistics knowledge: sampling, probability, capability, SPC.
• Experience generating and analyzing quality metrics.
• Proven problem-solving skills and RCA methodologies.
• Ability to work independently and propose solutions.
• Knowledge of GD&T and mechanical drawings.
• Ability to promote teamwork and drive continuous improvement.
• Proficient in MS Office and statistical software.

Responsibilities

• Lead quality activities in sustaining engineering and manufacturing.
• Review and approve product/process changes, ensuring regulatory compliance.
• Drive quality improvements and risk reduction across the hardware org.
• Analyze quality data and perform root cause analyses.
• Support sterilization validation and environmental monitoring programs.
• Collaborate with cross-functional teams to ensure quality system effectiveness.
• Provide input to COs, NCRs, and CAPA investigations.
• Support audits and training to maintain compliance.

Skills

Quality engineering

Statistical methods

Root cause analysis

Problem solving

GD&T knowledge

Independent work

Communication

MS Office

MiniTab

Risk assessment

Education

Bachelor’s degree in a technical field

Tools

MiniTab

MS Office

Gage R&R

Job description

Tandem Diabetes Care Inc. is seeking a Senior Quality Engineer to lead quality activities in sustaining engineering and manufacturing at our Barnes Canyon site.

You will oversee product and process changes, drive quality improvements, and support sterilization validation, environmental monitoring, and CAPA investigations. Candidates should have 5+ years in quality engineering for FDA-regulated hardware and strong knowledge of ISO 13485, FDA QMSR, and ISO 14971.