Quality Assurance Technician
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
14 hours ago
Vacancies:
1 Vacancy
Job Summary
Quality Technician Irvine CA (Onsite)
Department: Quality
Employment Type: FullTime NonExempt
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 inspectionrelated 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 longterm 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
Required Experience:
IC
Key Skills
- Quality Assurance
- Coordinate Measuring Machine
- Food Industry
- Food Safety Experience
- ISO 9001
- Math
- Food Processing
- Quality Control
- cGMP
- QA/QC
- HACCP
- Manufacturing
About Company
Fortive Corporation Overview Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product d ... View more
