Quality Control Inspector II (3-Month Contract)

Tandem Diabetes Care, Inc.; Irvine (CA); On-site; USD 37,000 - 41,000; Full time

Job summary

Tandem Diabetes Care, Inc. in Irvine, California, is seeking a Quality Control Inspector II for on-site testing and inspections of raw materials, sub-assemblies, and finished products. You will support development, quality, and manufacturing teams with lab testing, documentation, and calibration activities.

The role requires a 4+ year QC inspection background, knowledge of QSRs and cGMP, and strong documentation skills. This temporary on-site position offers day shift hours and onsite training.

Qualifications

• 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.
• Proficient with Microsoft Office and Internet.
• HS Diploma or equivalent required, with some post high school technical training preferred.

Responsibilities

• Performs inspections on raw materials and sub-assemblies to identify non-conforming material.
• Performs testing on prototype and production product to support Product Development, Quality, and Manufacturing Technology engineers.
• Maintains calibration and preventive maintenance records for inspection equipment.
• Documents work on appropriate forms as required by test protocols and SOPs.
• Tests components, in-process, and finished product independently following established SOPs and WIs.
• Complies with safety and operating policies and procedures.

Skills

QSRs knowledge

cGMP documentation

Electromechanical assembly

Written/verbal communication

Teamwork

Prioritization

MS Office

Education

HS Diploma or equivalent

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 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.

COMPENSATION:

The starting base pay range for this position is $27.00 - $30.00 per hour. Base pay will vary based on job-related knowledge, skills, experience and may also fluctuate depending on candidate’s location and the overall job market.

Please note that is a temporary position. As a temporary employee you will be employed through a staff agency partner. Benefits during your temporary assignment may be provided by the staffing agency. Access to Tandem sponsored benefits is contingent upon conversion from temporary to regular full-time status. Conversion is determined based upon business need and job performance.

YOU SHOULD KNOW:

Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information.

Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.

SPONSORSHIP:

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time

WHY YOU’LL LOVE WORKING HERE:

At Tandem, we believe joy fuels excellence. That’s why we’ve built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.

BE YOU, WITH US!

We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.

Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.

REFERRALS:

We love a good referral! If you know someone who would be a great fit for this position, please share!

APPLICATION DEADLINE:

The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.

Make a move that matters. Join Tandem Diabetes Care, where we’re turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.

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