Flextronics
Quality Technician
USA, TX, Austin
Sponsorship not specifiedDetected 4 days ago
AccessibilityERPFDA RegulatoryMedical DevicesCollaboration
About the role
- Shift: F Shift 6:00pm-6:00am (Sunday, Monday, Tuesday every other Wednesday)
Responsibilities
- Support or execute final product release decisions based on DHR review outcomes.
- Identify and escalate data integrity issues and support remediation.
- Support Nonconformances (NCs), deviation documentation.
- Perform comprehensive review of Device History Records (DHRs) to ensure completeness, accuracy, and compliance with approved procedures, Device Master Record (DMR), and regulatory requirements (e.g., FDA 21 CFR 820.184, ISO 13485).
- Perform reconciliation activities to ensure that all components are accounted for and documented accurately.
- Support audit activities by retrieving and explaining DHR documentation
- Maintain compliance with internal quality systems and external regulatory standards.
- Cross-functional Collaboration with Manufacturing, Quality Engineering and Document Control.
- Provide feedback on documentation errors and trends to drive continuous improvement.
- Support training efforts to improve documentation accuracy and compliance.
Requirements
- Verify all required manufacturing and quality records are present, including:
Benefits
- Full range of medical, dental, and vision plans
- Life Insurance
- Short-term and Long-term Disability
- Vacation and Paid Sick Time
- Tuition Reimbursement
Equal opportunity
- Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities.
Visa & Work Authorization
- Is Sponsorship Available?
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This listing is sourced directly from Flextronics's careers page and normalized into a canonical job model.