Job Description
Job Summary
Located in the vibrant city of Irvine, CA, this role offers the opportunity to work in a dynamic environment where innovation meets quality. The Supplier Quality Analyst is responsible for ensuring that suppliers of materials, components, and services used in medical devices consistently meet quality, regulatory, and risk requirements. This role supports compliance with FDA Quality System Regulation (21 CFR 820) and ISO 13485 through supplier performance monitoring, corrective action management, and risk-based supplier controls.
Key Responsibilities
Located in the vibrant city of Irvine, CA, this role offers the opportunity to work in a dynamic environment where innovation meets quality. The Supplier Quality Analyst is responsible for ensuring that suppliers of materials, components, and services used in medical devices consistently meet quality, regulatory, and risk requirements. This role supports compliance with FDA Quality System Regulation (21 CFR 820) and ISO 13485 through supplier performance monitoring, corrective action management, and risk-based supplier controls.
Key Responsibilities
- Manage and maintain supplier qualification, monitoring, and re-evaluation activities in accordance with 21 CFR 820.50 (Purchasing Controls) and ISO 13485.
- Monitor supplier quality performance using KPIs such as defect rates, corrective action trends, and supplier risk levels.
- Maintain approved supplier lists (ASL) and supplier quality records per document control requirements.
- Issue, track, and evaluate Supplier change requests.
- Escalate supplier quality risks and support remediation and improvement plans.
- Review and support supplier-initiated or internally driven changes that may impact product quality or compliance (materials, processes, manufacturing location).
- Collaborate with Engineering and Regulatory Affairs to assess supplier changes requiring validation, verification, or regulatory impact evaluation.
- Provide supplier quality input for management reviews and quality metrics.
- Ensure supplier quality documentation is accurate, complete, and maintained in the electronic Quality Management System (eQMS).
- Ensure supplier activities comply with internal procedures, regulatory requirements, and quality system expectations.
- Bachelor’s degree in Engineering, Quality, or a related field;or equivalent experience.
- 2–5 years of experience in Supplier Quality, Quality Assurance, or Manufacturing within a medical device or other regulated environment.
- Working knowledge of 21 CFR 820, ISO 13485, and supplier control requirements.
- Proficiency in Microsoft Excel and data analysis.
- Strong understanding of regulated quality systems
- Analytical, detail-oriented problem-solving mindset
- Clear written and verbal communication
- Ability to influence suppliers and internal stakeholders
- Strong organizational and time-management skills
Numbers & Facts
| Location | Irvine, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $45 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Analysis Skillsunmatched
- Change Requests/Ordersunmatched
- Code of Federal Regulationsunmatched
- Corrective Actionunmatched
- Data Analysisunmatched
- Detail Orientedunmatched
- Document Controlunmatched
- Documentationunmatched
- FDA Requirementsunmatched
- ISO (International Organization for Standardization)unmatched
- Manufacturingunmatched
- Medical Equipmentunmatched
- Microsoft Excelunmatched
- Organizational Skillsunmatched
- Performance Analysisunmatched
- Performance Metricsunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Process Improvementunmatched
- Process Manufacturingunmatched
- Procurement Managementunmatched
- Quality Assuranceunmatched
- Quality Managementunmatched
- Quality Metricsunmatched
- Quality Monitoringunmatched
- Quality System Requirements (QSR)unmatched
- Regulationsunmatched
- Regulatory Requirementsunmatched
- Riskunmatched
- Time Managementunmatched
- Validation Testingunmatched
- Vendor/Supplier Evaluationunmatched
- Vendor/Supplier Managementunmatched
- Vendor/Supplier Quality Managementunmatched
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