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

JenaValve

Irvine, CA

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.

Required Education and Experience:

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.

Skills and Abilities Required for This Job:

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.

Physical Requirements:

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.

Apply

Vacancy posted 4 days ago

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