Cleanroom Quality Inspector – GMP/ISO Compliance

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

Job summary

Kelly Outsourcing Consulting Group is seeking a Quality Inspector – Cleanroom in Irvine, CA. The role involves inspecting manufacturing processes, ensuring compliance with FDA GMPs and ISO 13485, and maintaining documentation accuracy in a cleanroom setting.

The position offers benefits and long-term engagement with routine nonconformance investigations, continuous improvement, and cross-functional collaboration in a regulated medical device environment.

Qualifications

• 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

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

Skills

Attention to detail

Organizational skills

Communication skills

Time management

Education

High School diploma

Job description

Kelly Outsourcing Consulting Group is seeking a Quality Inspector – Cleanroom in Irvine, CA. The role involves inspecting manufacturing processes, ensuring compliance with FDA GMPs and ISO 13485, and maintaining documentation accuracy in a cleanroom setting.

The position offers benefits and long-term engagement with routine nonconformance investigations, continuous improvement, and cross-functional collaboration in a regulated medical device environment.