What are the responsibilities and job description for the Spec 3, Quality Assurance position at MillenniumSoft Inc?
Position : Supplier Quality Analyst
Location : Irvine, CA
Duration : 6 Months
Total Hours/week : 40.00
1st Shift
Client : Medical Devices Company
Job Category : Quality
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT
Job Description
Job Summary
Location : Irvine, CA
Duration : 6 Months
Total Hours/week : 40.00
1st Shift
Client : Medical Devices Company
Job Category : Quality
Employment Type : Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT
Job Description
Job Summary
- 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), ISO 13485 through supplier performance monitoring, corrective action management, and risk-based supplier controls.
- 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