Quality Engineer II

Tasks

• Support QMS integration, improvement, and remediation activities
• Conduct QMS gap assessments and develop corrective action plans
• Ensure compliance with ISO 13485 and FDA 21 CFR Part 820
• Manage CAPA, root cause analysis, and nonconformance investigations
• Support document control and quality procedure updates
• Assist with internal, supplier, and regulatory audits
• Support risk management and quality compliance activities
• Collaborate with cross-functional teams to maintain regulatory readiness

Requirements

• 3–5 Years
• Quality Management Systems (QMS) – MUST HAVE
• ISO 13485 – MUST HAVE
• Medical Device Quality Experience – MUST HAVE
• FDA 21 CFR Part 820 / QSR – MUST HAVE
• CAPA & Root Cause Analysis
• QMS Gap Assessments & Remediation
• Document Control & Audit Readiness
• Nonconformance Management
• Risk Management
• MDSAP / ISO 14971 – Preferred
• QMS Integration or Remediation Experience – Preferred

Schedule

• Contract
• Onsite(ONLY W2 NO C2C)

How to apply

• Share your updated resume by email

Location

• Irvine, CA