Quality Assurance Technician

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: 1st

Hourly Pay Range: $

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.