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Tandem Diabetes Care · 1 day ago

Quality Control Inspector II (3-Month Contract)

Irvine, CA

Full-time, Contract

Onsite

Mid Level

$27/hr - $30/hr

4+ years exp

Tandem Diabetes Care is a leader in the diabetes technology industry, committed to creating innovative products for people living with diabetes. The Quality Control Inspector II will perform inspections and testing on raw materials and finished products, ensuring compliance with established standards and improving lab efficiency.

Medical Device

No H1B

Responsibilities

Performs inspections and testing on raw materials and sub-assemblies to identify non-conforming material and product and may assist in evaluation of non-conformances

Performs routine and non-routine testing of sub-assemblies and finished product with limited supervision according to material and product specifications, following Standard Operation Procedures (SOPs) and Work Instructions (WIs)

Compiles data for evaluation of department Key Process Indicators (KPIs)

Assists with validating 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

Qualification

QSR knowledgeCGMP documentationQC Inspection experienceElectromechanical device assemblySampling methodologiesVisual inspection systemsMicrosoft OfficeTeam cooperationCommunication skills

Required

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

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

Preferred

Some post high school technical training preferred

Experience with medical device consumer products a plus

Company

Tandem Diabetes Care

Glassdoor3.6

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers.

Founded in 2006

San Diego, California, US

1001-5000 employees