Supplier Quality Analyst - Onsite; Exp in medical device or regulated environment

Job Category

Quality

Contract on W2 (US Citizens, GC Holders, GC EAD, OPT, EAD, CPT)

Supplier Quality Analyst

Irvine, CA

6 Months

40.00

1st Shift

Medical Devices Company

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.

• 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, 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.

This position is a non‑priority hiring. The HR generalist will ask the hiring manager if the role is a priority. If so, we ask the hiring manager to confirm or change the priority status then optionally raise an EDR (employee disability request) or ADA accommodation request, or in rare cases we might find a hiring-handover email with no more contact extit{contact}.

Candidates should seek guidance accordingly. No further EEO statement is required in the description.