Spec 3, Quality Assurance

Position : Supplier Quality Analyst

Location : Irvine CA

Duration : 6 Months

Total Hours/week : 40.00

1^st 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.

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.

Required Qualifications

• Bachelors 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.

Key Skills & Competencies

• 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