Quality Technician - Cleanroom

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

Email resumes to [email protected]

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. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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