QA Technician

Job Scope

The Quality Assurance Technician I is responsible for reviewing and verifying Device History Records (DHRs) to ensure compliance with internal procedures, FDA regulations (21 CFR Part 820), and ISO standards (e.g., ISO 13485). This role supports the release of intermediate materials and finished medical devices and ensures product quality and regulatory compliance.

Key Duties and Responsibilities

• Review completed Device History Records (DHRs) and other quality records for completeness, accuracy, and compliance with documented procedures and execute product release under a production schedule
• Verify that all required production, inspection, and test documentation is complete and meets release criteria
• Identify and document any discrepancies or non-conformances found during DHR review, generating Non-Conformance Reports (NCs) as needed
• Log, file, maintain and archive various QA reports & records
• Maintain and track key performance metrics
• Perform QA Gemba walkthroughs of manufacturing operations to drive continuous improvement and compliance
• Assist in continuous improvement of DHR review processes and related quality procedures
• Participate in quality investigations (e.g., CAPA, NCs) related to DHR errors or product quality issues as needed
• Assist other Quality Assurance personnel in data collection as needed
• Other duties as assigned

Education, Experience, and Qualifications

• Associate's Degree in a life science or engineering or equivalent related experience (Preferred)
• H.S. Diploma (Required)
• Minimum Years of Experience: 1+ Years Experience in FDA regulated manufacturing environment, previous Quality experience (Preferred)
• 1+ Years Experience with participating in formal audits preferred (Preferred)
• Certification in a quality discipline preferred, such as CQT, CCT, CQI, etc. (Preferred)

Training and Skills

• Good verbal and written communication skills
• Computer skills (Microsoft Windows and Office programs), familiarity with Oracle preferred
• Highly organized with proven time management and prioritization skills
• Ability to handle the pressure of meeting tight deadlines