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

Jenavalve Technology; Irvine (CA); On-site; USD 28,000 - 39,000; Part time

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

Job Details

Job Location: Irvine, CA 92618

Position Type: Contractor

Education Level: High School

Salary Range: $24.20 - $24.20 Hourly

Job Title: Inspector, Quality Control (Delivery System)

Roles: 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.
• 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 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.

Qualifications

• High school diploma or equivalent required. Candidates without a diploma may demonstrate equivalent competency through a validated external assessment.
• Minimum 1 year of experience in Quality Control or equivalent Manufacturing Inspection within the medical device industry or other regulated precision manufacturing environments.
• Basic knowledge of quality systems, GDP/GMP, and inspection techniques.
• Ability to follow detailed work instructions and maintain accurate documentation.
• The level of this role (Technician I, II, or III) will be determined based on the candidate’s experience, technical skills, and demonstrated competencies relevant to the position.

Skills and Abilities

• Adhere to company code of conduct and contribute to fostering a professional, collaborative and respectful team working environment.
• Work effectively in a regulated manufacturing / cleanroom environment.
• Show strong attention to detail while performing visual and functional inspections.
• Follow written procedures, work instructions, and quality standards.
• Good communication skills (verbal and written) and ability to work collaboratively with cross‑functional teams.
• Learn and apply inspection techniques and tools.
• Basic understanding of GMP documentation practices.
• Read, comprehend and speak English.
• Basic computer skills (MS Office and documentation systems).

Physical Requirements

• Requires prolonged periods of standing and sitting to support inspection, testing, and review activities.
• Work in a controlled cleanroom environment while wearing full cleanroom gowning including gown/coveralls, gloves, mask, hairnet, boot covers, and other PPE as needed.
• Follow clean rooms, laboratory, and site safety protocols at all times.
• Use inspection and testing equipment as part of routine job duties.
• Push, pull, twist, climb, balance, stoop, kneel, and crawl as required.
• Perform repetitive motions such as reaching and grasping.
• Lift or move materials up to 25 pounds.