Quality Assurance Technician

**Quality Technician - Irvine, CA (On‑site)** **Department:** Quality **Employment Type:** Full‑Time, Non‑Exempt 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. **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 **Qualifications** **Required** + 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 **Preferred** + 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) **Physical Requirements** + Ability to lift up to 40 lbs + Frequent sitting and use of hands/fingers for documentation review + Occasional standing, walking, reaching, stooping, kneeling, or climbing + Close vision required for document review and inspection **Fortive Corporation Overview** Fortive's essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare. We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. We're a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to advanced technologies that help providers focus on exceptional patient care. We are a diverse team 10,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact. At Fortive, we believe in you. We believe in your potential-your ability to learn, grow, and make a difference. At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone. At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating. Fortive: For you, for us, for growth. **About Advanced Sterilization Products** ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP's mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP's products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning. We Are an Equal Opportunity Employer. Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@. **Bonus or Equity** This position is also eligible for bonus as part of the total compensation package. **Pay Range** The pay range for this position is $27.75 -$41.63 hourly This position is also eligible for bonus as part of the total compensation package. The pay range for this position is $27.75 -$41.63 hourly We are an Equal Opportunity Employer Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@.

Created: 2026-04-02