Quality Technician - Cleanroom

Kelly Services; Irvine (CA); On-site; USD 39,000 - 41,000; Full time

Benefits offered by this job

Medical benefits

Paid time off

401K

Holiday pay

Job summary

Kelly Outsourcing Consulting Group is seeking a Quality Inspector - Cleanroom in Irvine, CA to ensure manufacturing processes and documentation meet FDA GMPs and ISO 13485 standards. The role emphasizes accuracy, nonconformance investigations, and cross‑functional quality improvement in a cleanroom environment.

The successful candidate will handle DHRs, Process Instructions, Device History Records, and controlled documents, supporting continuous improvement and digital archival for quality

Qualifications

• High School diploma required.
• Experience in manufacturing, quality inspection and cleanroom environments.
• Familiarity with FDA GMPs, ISO 13485 and quality system procedures.
• Strong attention to detail and ability to work under pressure.

Responsibilities

• Inspect the manufacturing process and review DHRs for process information and Good Documentation Practices.
• Support improvements to streamline documentation, Verification & Validation activities, and product testing.
• Verify Process Instructions, Device History Records, Manufacturing Operating Procedures, and other controlled documents.
• Work in a cleanroom environment using required tools and adhere to quality procedures.
• Generate nonconformance reports and assist in investigations, dispositions, and corrective actions.

Skills

Attention to detail

Time management

Multitasking

Communication

Self-motivation

Education

High School diploma

Job description

Quality Inspector - Cleanroom

Kelly Outsourcing Consulting Group has an opening for a Quality Inspector - Cleanroom for a long-term engagement at one of our Global medical device clients in Irvine CA. The role is eligible for medical benefits, paid time off including vacation (PTO), and holidays, 401K, and annual performance reviews. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts

Location:

Irvine CA

Compensation:

$28-30 an hour

Schedule

Monday-Friday, 8AM-5PM

Summary:

The Quality Inspector – Cleanroom inspects manufacturing processes, products, and related documentation to ensure compliance with company procedures, FDA GMPs, and ISO 13485 standards. This role supports documentation accuracy, nonconformance investigations, continuous improvement, and cross-functional quality initiatives in a cleanroom environment.

Responsibilities:

• Inspect the manufacturing process and review the associated DHRs for process information and Good Documentation Practices.
• Support the continuous improvements to streamline the documentation process, Verification & Validation activities, and testing of products.
• Verifies Process Instructions, Device History Records, Manufacturing Operating Procedures, Process-Specifications, Device Specifications, and other controlled documents against actual operations.
• Understands the clean room, manufacturing process and quality functions as well as the required documentation processes for each.
• Ability to use FDA GMPs/ISO 13485 and BWI quality system procedures to assess and ensure compliance of BWI processes and specifications.
• Generates nonconformance reports and assists in investigation, final dispositions, and corrective actions as necessary.
• Ability to work in a cleanroom, which involves use of cleanroom tools to perform duties and responsibilities.
• Performs other quality related responsibilities as needed
• Verification and inspection of assemblies, subassemblies, and manufacture product before shipment.
• Responsible for data collection, review, and filling of data records.
• Work in group (team) environment and independently, on specific tasks and multi-tasks as needed.
• Responsible for communication business related issues or opportunities to next management level.
• Responsible for the creation of digital records from physical Device History Records and other documentation generated in the cleanroom for archival and quality review

Minimum Experience:

• High School degree is required
• Experience in manufacturing, quality inspection, and cleanroom environments.
• Experience with documentation, DHRs, Good Documentation Practices, and quality records.
• Familiarity with FDA GMPs, ISO 13485, and quality system procedures.
• Strong attention to detail, organization, communication, and time-management skills.
• Able to multitask, work under pressure, and collaborate cross-functionally.
• Self-motivated, proactive, and able to work independently.
• P#1

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Why Kelly Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en).

Kelly Services is proud to be an Equal Employment Opportunity and Aff

We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.