Quality Control Inspector

Quality Control Inspector

KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for a Quality Control Inspector in Irvine, Ca. The Quality Control (QC) Inspector inspects purchased parts, assemblies, accessories, and materials for conformance to requirements and specifications. The QC Inspector examines items for defects in materials, work, and damage. The Inspector is responsible for ensuring conformance of incoming materials to the requirements of medical device components and finished goods.

Essential Duties and Responsibilities:

• Performs visual, dimensional and functional inspection and testing according to documented policies and procedures.
• Records inspection and test data as prescribed by written instructions and procedures.
• Reviews supplier-provided documentation to determine compliance with specifications and drawings; maintains accurate and complete records for each part, including the Receiving Inspection (RI) log; completes, scans, and files RI quality records; and ensures status is updated electronically in the Enterprise Resource Planning system.
• Label all inspected components and materials accordingly, following visual inspection and final disposition.
• Work collaboratively and communicate proactively with Procurement, R&D Engineering, Manufacturing Engineering, Receiving, and other departments to ensure timely and high-quality execution of RI responsibilities.
• Strictly comply with standard operating procedures and work instructions, recommending improvements and enhancements to processes, and performing other duties as determined by management.

Qualifications / Job Requirements:

• High school diploma / GED or an equivalent combination of education and work experience.
• A minimum of 1-3 years' experience working in a regulated environment, medical device or pharma/biotech quality management system (i.e., ISO 13485, ISO 14971, FDA 21 CFR Part 820) is preferred.
• Experience with incoming or in-process inspection, able to read and understand Engineering Drawings and Part Specifications.
• Experience participating in cross-functional teams to support business priorities is preferred.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Able to use measuring equipment such as calipers, micrometers, gages, etc.
• Proficient in MS Office programs including Word, Excel and Arena is a plus.
• Strong understanding of quality control standards and testing techniques preferred.
• Result-oriented, positive 'can-do' attitude with demonstration of appropriate urgency and initiative.