Onsite QC Inspector II — Medical Devices (FDA-regulated)

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 for an onsite role in Irvine, CA. The position involves performing inspections, tests, and data collection to ensure raw materials, sub-assemblies, and finished products meet specifications under FDA-regulated standards.

Responsibilities include documenting results, maintaining calibration, and assisting in improving testing methodologies. A high standard of cGMP and QSR adherence is required, with 4+ years of related experience

Qualifications

• HS Diploma or equivalent required, with some post high school technical training preferred.
• 4+ years relevant QC Inspection experience, preferably in an FDA regulated industry.
• Experience with QSRs and cGMP including basic knowledge of QC systems.
• Experience utilizing sampling methodologies and tools.
• Experience measuring materials with visual inspection systems.
• Experience with medical device consumer products a plus.

Responsibilities

• Performs inspections on raw materials and sub-assemblies to identify non-conforming material and product.
• Performs testing of sub-assemblies and finished product under SOPs and WIs.
• Projects data for KPI evaluation and assists in validating inspection processes.
• Performs dimensional inspections on raw materials and components.
• Tests prototype and production product to support engineers and QA.
• Maintains lab equipment calibration and documentation.

Skills

QSRs

cGMP

Device assembly

Communication

Teamwork

Prioritization

MS Office

Education

HS Diploma

Tools

QC equipment

Measurement tools

Vision inspection systems

Job description

Tandem Diabetes Care is seeking a Quality Control Inspector II for an onsite role in Irvine, CA. The position involves performing inspections, tests, and data collection to ensure raw materials, sub-assemblies, and finished products meet specifications under FDA-regulated standards.

Responsibilities include documenting results, maintaining calibration, and assisting in improving testing methodologies. A high standard of cGMP and QSR adherence is required, with 4+ years of related experience