Delivery System Quality Inspector

Jenavalve Technology

Irvine (CA)

On-site

USD 28,000 - 39,000

Part time

14 days+
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Job summary

Jenavalve Technology in Irvine, CA is seeking an Inspector, Quality Control for Delivery System to perform in-process and final inspections, verify DHRs, and release products to Finished Goods Inventory in a controlled cleanroom environment.

You will review labeling, ensure GDP/GMP adherence, and collaborate with Quality Engineers on NCRs and corrective actions, while maintaining accurate documentation and complying with company policies.

Qualifications

  • High school diploma or equivalent required; diploma waiver possible with proven competency.
  • Minimum 1 year experience in Quality Control or medical device manufacturing.
  • Knowledge of GDP/GMP and inspection techniques.
  • Ability to follow detailed work instructions and document accurately.

Responsibilities

  • Perform in-process and final quality inspections of Delivery System subassemblies and finished products, including visual inspection, dimensional verification, and functional testing per approved work instructions, SOPs, and quality procedures.
  • Review Device History Records (DHR) for completeness, accuracy, and conformance to acceptance criteria, ensuring compliance with GDP/GMP.
  • Conduct inspection of device labeling, including UDI human-readable content and barcode verification.
  • Release DS products to Finished Goods Inventory (FGI) upon successful completion of all quality requirements.
  • Identify quality issues or process deviations during inspection activities and initiate Non-Conformance Reports (NCRs); assist with material containment, root cause investigations, and corrective actions.
  • Support engineering and quality teams in process validations.
  • Maintain line clearance and organize workstations in accordance with cleanroom and company procedures.
  • Complete required training and maintain qualification for assigned inspection processes.

Skills

Attention to detail
Communication skills
Regulated environment
GMP knowledge
Teamwork

Education

High school diploma

Tools

MS Office
Documentation systems
Inspection tools

Job description

Jenavalve Technology in Irvine, CA is seeking an Inspector, Quality Control for Delivery System to perform in-process and final inspections, verify DHRs, and release products to Finished Goods Inventory in a controlled cleanroom environment.

You will review labeling, ensure GDP/GMP adherence, and collaborate with Quality Engineers on NCRs and corrective actions, while maintaining accurate documentation and complying with company policies.

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