Inspector , Quality Control; Delivery System - Temp

Job Title

Inspector, Quality Control (Delivery System)

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

Individual Contributor

Senior Manager, Quality Engineering

Irvine, CA — Corporate Office/Controlled Clean Room Environment

• 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.

• 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.

• 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.
• High school diploma or equivalent required. Candidates without a diploma may demonstrate equivalent competency through a validated external assessment designed to evaluate comprehension, language, and related abilities at a high school level.
• Minimum 1 year of experience in Quality Control or equivalent Manufacturing Inspection experience within the medical device industry or other regulated precision manufacturing environments required.
• Basic knowledge of quality systems, GDP/GMP, and inspection techniques.
• Ability to follow detailed work instructions and maintain accurate documentation.

• Must be able to adhere to company code of conduct and contribute to fostering a professional, collaborative and respectful team working environment.
• Ability to work effectively in a regulated manufacturing / cleanroom environment.
• Strong attention to detail while performing visual and functional inspections.
• Ability to follow written procedures, work instructions, and quality standards.
• Good communication skills (verbal and written) and ability to work collaboratively with cross-functional teams.
• Ability to learn and apply inspection techniques and tools.
• Basic understanding of GMP documentation practices.
• Ability to read, comprehend and speak English, and good communication skills required.
• Basic computer skills (MS Office and documentation systems).
• Basic computer skills including proficiency with documentation systems and MS Office.

• Requires prolonged periods of standing and sitting to support inspection, testing, and review activities.
• Ability to work in a controlled cleanroom environment while wearing full cleanroom gowning including gown/coveralls, gloves, mask, hairnet, boot covers, and other PPE as needed.
• Must be able to follow clean rooms, laboratory, and site safety protocols at all times.
• May require use of inspection and testing equipment as part of routine job duties.
• Must be able to push, pull, twist, climb, balance, stoop, kneel, and crawl.
• Must be able to perform repetitive motions such as reaching and grasping.
• Ability to lift or move materials up to 25 pounds.