Quality Inspector I - AID

Werfen • San Diego, CA

409d

About The Position

The Quality Inspector I is responsible for performing and documenting inspections and testing according to established sampling plans and specifications. This role involves identifying and documenting nonconforming products, generating nonconformance reports (NCRs), and ensuring that materials and products meet quality specifications before acceptance for use.

Requirements

• High School Diploma or GED required.
• Three years of work experience required, with at least one year in inspection.
• Experience in an ISO 13485 or FDA regulated environment preferred.
• Basic experience with Enterprise Resource Planning (ERP) systems preferred, with SAP strongly preferred.
• Advanced ability to manage multiple tasks in a fast-paced environment.
• Basic problem-solving skills and ability to deal with concrete variables in non-standardized situations required.
• Basic knowledge in the use of gauges and measuring devices preferred.
• Basic knowledge of quality control principles for in vitro diagnostics manufacturing.
• Working knowledge of units of measure and basic math skills.
• Basic proficiency in Microsoft Office Suite: Word, Excel, Access, Outlook, PowerPoint preferred.
• Good communication skills and strong attention to detail.

Nice To Haves

• Experience working in an ISO 13485 or FDA regulated environment.
• Basic knowledge of the interconnections between the nonconformance process and the use of nonconforming items.

Responsibilities

• Conduct visual, dimensional, and functional inspections on incoming materials, components, assemblies, and products as per procedures and specifications.
• Perform inventory computer transactions for inspection completion, transfers, and releases.
• Ensure measurement, test, and inspection equipment is calibrated and in good condition.
• Maintain proper identification, traceability, and inspection/test status of materials.
• Generate nonconformance reports and execute disposition of nonconforming products.
• Pull quarantine components for departments as needed.
• Conduct environmental monitoring, including sampling air, surface, and deionized water systems.
• Process water samples for the Cleaning Validation Program.
• Complete, organize, review, maintain, and archive quality control records.
• Coordinate disposal of waste, expired materials, and hazardous materials.

What This Job Offers

• Job Type: Full-time
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: High school or GED