Spec 3, Quality Assurance - Onsite (Urgent Need)

MillenniumSoft Inc; Irvine (CA); On-site; USD 28,000 - 34,000; Part time

Job summary

MillenniumSoft Inc. in Irvine, CA is seeking a Supplier Quality Analyst to ensure medical device supplier materials meet quality and regulatory standards. On-site role focusing on supplier qualification, monitoring, and change control to uphold FDA and ISO 13485 compliance.

Responsibilities include tracking supplier performance via KPIs, maintaining ASL, handling supplier change requests, and coordinating with Engineering and Regulatory Affairs for validations and regulatory impact assessments.

Qualifications

• 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.

Responsibilities

• Manage and maintain supplier qualification, monitoring, and re-evaluation activities in accordance with 21 CFR 820.50 and ISO 13485.
• Monitor supplier quality performance using KPIs such as defect rates and corrective action trends.
• 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.
• Collaborate with Engineering and Regulatory Affairs to assess supplier changes requiring validation or regulatory impact evaluation.
• Provide supplier quality input for management reviews and quality metrics.
• Ensure supplier quality documentation is accurate and maintained in the eQMS.
• Ensure supplier activities comply with internal procedures and regulatory requirements.

Skills

Analytical

Written communication

Verbal communication

Time management

Education

Bachelor’s degree in Engineering, Quality, or a related field

Tools

Microsoft Excel

Job description

Job Title - Spec 3, Quality Assurance

Job Location - Irvine, California

pay rate-$20-25/hr

Duration: 6 Months

Job Description

On site 5 days

Education Bachelor Engineering or Quality

Windchill / PLM Will red line Doc's

Doc control , Validating systems , Updating supplier change request , reveiwing Quality Agreements

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

• 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.

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 stakeholdersStrong organizational and time-management skills