Quality Assurance Technician

Fortive • Irvine, CA

31d • Onsite

About The Position

The Quality Technician is responsible for reviewing batch records / Device History Records (DHRs) for accuracy, completeness, and compliance with Good Documentation Practices (GDP) and applicable Quality System Regulations (QSR). The role also processes SAP transactions required for material status changes and lot release. Additional responsibilities include resolving documentation discrepancies and supporting quality activities as needed.

Requirements

• High School Diploma or equivalent
• Minimum 2 years of experience in QA, batch record review, or manufacturing documentation
• Knowledge of Good Documentation Practices (GDP)
• Ability to read and interpret engineering drawings
• Proficient with Microsoft Office applications
• Ability to use basic inspection tools (calipers, micrometers, height gages, barcode scanners)
• Effective verbal and written communication skills
• Ability to manage multiple tasks simultaneously and prioritize urgent items
• Strong long‑term memorization skills

Nice To Haves

• Experience performing batch/DHR review in a medical device environment
• SAP experience, especially in Quality Management or Master Data modules
• Knowledge of 21 CFR 820 and ISO 13485
• Familiarity with ALCOA+ data integrity principles
• ASQ certification (CQI, CQT)

Responsibilities

• Review batch records / DHRs for compliance with GDP and internal procedures
• Identify and correct documentation errors by coordinating with Production, QC, and other departments
• Perform SAP transactions related to quality decisions, material status, and lot release
• Ensure all documentation entries meet QSR, GDP, and ISO requirements
• Support product disposition through documentation verification and SAP processing
• Review supplier inspection/test documentation as assigned
• Provide support for inspection‑related tasks and documentation checks when required
• Maintain accurate records and follow established procedures and work instructions
• Perform visual and dimensional inspection of medical devices
• Manage multiple queues and tasks based on urgency and demand timelines

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED