Quality Control Inspector II (3-Month Contract)

Tandem Diabetes Care Inc.; Irvine (CA); On-site; USD 37,195 - 41,328; Full time

Job summary

Tandem Diabetes Care Inc. is seeking a quality control inspector in Irvine, California. The role involves testing and inspections of materials and products, ensuring compliance with quality standards.

This temporary position operates Monday to Friday from 8:00 AM to 5:00 PM PST. Candidates should possess 4+ years of QC experience in a regulated environment and strong documentation skills. Pay ranges from $27.00 to $30.00 per hour based on qualifications.

Qualifications

• Strong understanding of QSRs and cGMP regulations.
• Minimum 4+ years relevant QC inspection experience in FDA regulated industry.
• Experience with medical device consumer products preferred.

Responsibilities

• Inspections and testing on raw materials and sub‑assemblies.
• Compile data for department Key Process Indicators (KPIs).
• Maintain performance and calibration of lab equipment.

Skills

cGMP documentation skills

team cooperation

prioritization

Microsoft Office proficiency

Education

High School Diploma or equivalent

Post-high school technical training

Job description

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.
• 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, follows 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

Location: Irvine, California. This position is fully onsite.

Schedule: Monday – Friday, 8:00AM – 5:00PM PST.

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 make 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.
• High School Diploma or equivalent required, with some post‑high school technical training preferred.
• Minimum 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.

This is a temporary position. A temporary employee 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.

EEO Statement

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 welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.