Quality Control Inspector II (3-Month Contract)

Tandem Diabetes Care Europe B.V.; Irvine (CA); On-site; USD 55,000 - 85,000; Full time

Job summary

Tandem Diabetes Care Europe B.V. is seeking a Quality Control Inspector II to perform inspections and testing of raw materials, sub-assemblies, and finished products, ensuring compliance with SOPs, WIs, GDP/GLP/GMP, and data traceability.

This onsite role is based in Irvine, CA and supports product development and manufacturing teams. Responsibilities include maintaining lab equipment, documenting tests, and contributing to KPI reporting while upholding safety and regulatory standards in a

Qualifications

• Knowledge of QSRs and strong cGMP documentation.
• Experience with small scale electromechanical device assembly.
• Proficient with Microsoft Office and Internet.

Responsibilities

• Perform inspections on raw materials and sub-assemblies to identify non-conforming material.
• Test sub-assemblies and finished product per SOPs and WIs.
• Compile data for KPI evaluation.
• Assist in validating inspection and testing processes.

Skills

QSR knowledge

cGMP documentation

Electromechanical assembly

Communication skills

Team collaboration

Prioritization

MS Office

Education

HS Diploma or equivalent

Post-high school technical training

Tools

Lab equipment

Job description

GROW WITH US

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We'd love for you to team up with us to \"innovate every day\", put \"people first\", and take the \"no-shortcuts\" approach that has propelled us to become a leader in the diabetes technology industry.

STAY AWESOME

Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology - an advanced predictive algorithm that automates insulin delivery. But we're so much more than that. Our company's human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com

A DAY IN THE LIFE

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.

Quality Control Inspector II's at Tandem are also responsible for

• 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.

WHEN & WHERE YOU'LL WORK

Onsite: 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.

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

WHAT YOU'LL NEED

Knowledge, skills & abilities:

• 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.

Minimum certifications/educational level:

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

Minimum experience:

• 4+ years relevant QC Inspection experience, preferably in an FDA regulated industry.
• Experience with Q