Quality Control Inspector II

About the Company

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’re committed to innovation, putting people first, and taking a no‑shortcuts approach that has propelled us to become a leader in the diabetes technology industry.

Quality Control Inspector II performs inspections and testing on raw materials and sub‑assemblies to identify non‑conforming material and product. They assist in the evaluation of non‑conformances, conduct routine and non‑routine testing of sub‑assemblies and finished product with limited supervision according to material and product specifications, follow Standard Operation Procedures (SOPs) and Work Instructions (WIs), compile data for evaluation of department Key Process Indicators (KPIs), and validate inspection and testing processes.

• Performs dimensional inspections on raw materials and incoming components.
• Performs testing on prototype and production product to support Product Development, Quality, and Manufacturing Technology engineers.
• Performs testing using an automated vertical tension and compression machine.
• Performs flow testing using various flow measurement and pressure systems.
• Develops and maintains lab apparatus and test methods.
• Maintains performance and calibration of lab equipment.
• Prepares sample product for testing and maintains proper documentation for product traceability.
• Assists in ordering lab supplies, standards, solvents and tracking inventory.
• Works with Product Development and Quality engineers to improve existing testing methodologies and SOPs to increase lab efficiency.
• Properly documents all work on appropriate forms as required by test protocols and SOPs.
• Utilizes and maintains a laboratory notebook.
• Complies with safety and operating policies and procedures regarding equipment, materials, and the finished product.
• Tests components, in‑process, and finished product independently following established SOPs and WIs.
• Performs quality material and product measuring, testing and release using established SOPs and WIs.
• Interprets engineering specifications and drawings and performs inspections, product segregation and verification.
• Maintains department documentation, inventory of measurement equipment, and ensures calibration and preventive maintenance records for inspection equipment are current.
• Performs preventive maintenance on equipment, as required.
• Performs set‑up/preparation of equipment, cleaning, changeover of lines and general housekeeping.
• Maintains a safe work environment; thoroughly reads and understands the material safety data sheets (SDS) for proper handling of materials, follow operating and maintenance instructions for tools and machinery, and utilizes relevant manuals for proper operating procedures.
• Performs verification and validation activities in accordance with company QMS, ISO, and FDA standards.
• Understands and applies GDP, GLP, and GMP.
• Ensures work is performed in compliance with company policies including Privacy/HIPAA and other regulatory, legal, and safety requirements.
• Performs other assignments or projects as directed.

This position is fully onsite and open to candidates located in Irvine, California. Equipment for the role will be provided and training will occur onsite.

This position will work Monday – Friday from 8:00 AM – 5:00 PM PST.

• Knowledgeable with QSRs.
• Must have strong cGMP documentation skills.
• Working knowledge of small scale electromechanical device assembly operation.
• Ability to effectively share information regarding issues in written or verbal form and making recommendations in a clear and concise manner.
• Skilled at promoting team cooperation and a commitment to team success.
• Demonstrated ability to effectively prioritize and handle multiple priorities and complete assignments on time and with minimal errors.
• Proficient with Microsoft Office and Internet.

• HS Diploma or equivalent required, with some post‑high school technical training preferred.

• 4+ years relevant QC Inspection…