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Quality Assurance Specialist
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-06-02
Listing for:
millenniumsoft
Full Time
position Listed on 2026-06-02
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist / Manager, Quality Engineering, Quality Control / Manager, Quality Technician/ Inspector -
Engineering
QA Specialist / Manager, Quality Engineering
Job Description & How to Apply Below
Roles & Responsibilities
- Manage supplier qualification, monitoring, and re-evaluation activities
- Ensure compliance with purchasing controls and quality regulations
- Monitor supplier performance using KPIs, defect trends, and risk analysis
- Maintain Approved Supplier Lists (ASL) and supplier quality records
- Issue, track, and evaluate supplier change requests
- Escalate supplier quality risks and support remediation plans
- Review supplier or internal changes impacting product quality or compliance
- Collaborate with Engineering and Regulatory teams on validation and impact assessments
- Provide supplier quality inputs for management reviews and quality metrics
- Maintain accurate documentation within the electronic Quality Management System (eQMS)
- Ensure supplier activities align with internal procedures and regulatory expectations
- 2-5 years of experience in Supplier Quality, Quality Assurance, or Manufacturing
- Experience in medical device or regulated environments preferred
- Supplier Quality Management
- Quality Assurance & Compliance
- Knowledge of 21 CFR 820 & ISO 13485
- Supplier performance monitoring
- Risk assessment & problem-solving
- eQMS documentation management
- Data analysis & Microsoft Excel
- Strong communication skills
- Organizational & time-management abilities
- Bachelor's degree in Engineering, Quality, or related field
- Equivalent experience may also be considered
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