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JENAVALVE TECHNOLOGY INC

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Inspector I, Quality Control (Delivery System) - Temp to Hire

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Job Title: Inspector, Quality Control (Delivery System)

  • Inspector I, Quality Control (DS)
  • Inspector II, Quality Control (DS)
  • Inspector III, Quality Control (DS)

Role Level: Individual Contributor

Supervisor/Manager Title: Senior Manager, Quality Engineering

Job Location & Environment: Irvine, CA-Corporate Office/Controlled Clean Room Environment

Job Description Summary:

  • Manufacturing - Hourly
  • Responsible for performing quality control inspections, testing, and release activities for Delivery System (DS). Support in-process and final inspections, perform Device History Record (DHR) review and product release to Finished Goods Inventory. Identify issues and non-conformance and collaborate with Quality Engineers on NCR Initiation, investigation and follow up actions.

Job 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 Good Documentation Practices (GDP/GMP).
  • Conduct inspection of device labeling, including UDI human-readable content and barcode verification.
  • Responsible for release of 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 raw material inspection and material release to inventory as needed.
  • Support engineering and quality teams in process validations.
  • Participate in continuous improvement initiatives and provide practical feedback.
  • Maintain line clearance and organize workstations in accordance with cleanroom and company procedures.
  • Complete required training and maintain qualification for assigned inspection processes.
  • Adhere to company policies, quality system requirements, and safety procedures.
  • Maintain reliable and consistent attendance to support production operations, including punctual arrival and the ability to work full scheduled shifts and overtime as required to meet operational and production needs.
  • Other duties as assigned by management.
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