Quality Assurance Technician Eastridge Workforce Solutions is committed to connecting skilled professionals with meaningful career opportunities. We are seeking a Quality Assurance Technician to support our client's team.
Location: Aliso Viejo, CA
Shift: 1stHourly Pay Range: $25.00-30.00
Employment Type: Full Time
Schedule: Monday - Friday
Job Summary:
The Quality Assurance Technician is responsible for reviewing and maintaining manufacturing and quality records to ensure compliance with internal procedures, regulatory requirements, and Good Documentation Practices (GDP). This role plays a critical part in ensuring Device History Records (DHRs) are complete, accurate, and compliant prior to product release.
Essential Duties and Responsibilities:
Review completed Device History Records (DHRs) for accuracy, completeness, and compliance prior to product release.
Verify manufacturing, inspection, testing, labeling, and packaging records are properly completed and approved.
Ensure all required signatures, dates, lot numbers, serial numbers, and traceability information are present.
Identify discrepancies, missing information, or documentation errors and coordinate corrections with manufacturing or quality personnel.
Verify records contain no unauthorized changes, missing entries, backdating, or incomplete corrections.
Review handwritten and electronic records for compliance with document control procedures.
Support training and reinforcement of GDP requirements across operations teams.
Maintain controlled quality system documentation, including forms, logs, procedures, and records.
Ensure documents are properly routed for review, approval, revision, and archival.
Support document change activities, including Engineering Change Orders (ECOs), document revisions, and obsolete document management.
Maintain document retention and filing systems in accordance with company and regulatory requirements.
Support internal audits, external audits, and regulatory inspections by retrieving and organizing quality records.
Assist with nonconformance, CAPA, complaint, and deviation documentation as needed.
Requirements:
High school diploma or associate degree required; bachelor's degree preferred.2+ years of experience in quality assurance, manufacturing, or regulated industries preferred.
Experience in medical device manufacturing strongly preferred.
Familiarity with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and GMP/GDP requirements preferred.
Experience reviewing batch records, travelers, routers, or DHRs is highly desirable.
Exceptional attention to detail and strong organizational skills.
Ability to detect errors, inconsistencies, and missing information in documentation.
Strong understanding of documentation compliance and traceability requirements.
Comfortable working with cross-functional teams including Manufacturing, Quality, and Engineering.
Proficient in Microsoft Office and electronic document management systems (eQMS/ERP preferred).Strong written and verbal communication skills.
