Advanced Quality Control Inspector – Medical Devices

Regulatory Jobs; Irvine (CA); On-site; USD 37,000 - 41,000; Full time

Job summary

Tandem Diabetes Care is seeking a Quality Control Inspector II to join our onsite Irvine team. You will perform inspections on raw materials and products, execute tests per SOPs, and help maintain lab calibration and documentation to ensure traceability.

A strong QC background in a regulated environment is essential. Ideal candidates have 4+ years in QC inspection, familiarity with QSRs and cGMP, and the ability to document findings clearly.

Qualifications

• HS Diploma or equivalent required, some post high school technical training preferred.
• 4+ years of QC inspection experience, preferably in an FDA-regulated setting.
• Experience with QSRs and cGMP; basic QC systems knowledge.
• Experience using sampling methods and measurement tools.
• Experience with medical device consumer products is a plus.

Responsibilities

• Perform inspections on raw materials and sub-assemblies to identify non-conforming items.
• Test sub-assemblies and finished products per SOPs with limited supervision.
• Compile data for KPIs and assist validation of inspection processes.
• Maintain lab equipment calibration and documentation for traceability.
• Prepare samples and manage lab supplies and inventory.
• Document work per SOPs and maintain an accurate lab notebook.
• Support Product Development and QC engineers to improve testing methods.

Skills

QSRs

cGMP docs

Electromechanical assembly

Documentation

Prioritization

MS Office

Team collaboration

Education

HS Diploma

Technical training

Job description

Tandem Diabetes Care is seeking a Quality Control Inspector II to join our onsite Irvine team. You will perform inspections on raw materials and products, execute tests per SOPs, and help maintain lab calibration and documentation to ensure traceability.

A strong QC background in a regulated environment is essential. Ideal candidates have 4+ years in QC inspection, familiarity with QSRs and cGMP, and the ability to document findings clearly.