Qualifications

• Bachelor’s degree (science or related field)
• 6 months–2 years of experience in quality, compliance, or regulated manufacturing
• Experience with document control, record control, and CAPA systems
• Familiarity with regulated quality systems (ISO 13485, FDA, Health Canada, or EU MDR)
• Strong working knowledge of Microsoft Office (Word, Excel)

Preferred Skills

• Lead Auditor certification or internal audit experience
• Experience supporting regulatory submissions or Regulatory Affairs
• Medical device or IVD industry background

Day-to-Day Responsibilities

Insight Global is looking to hire a Quality Compliance Associate to support quality system compliance activities within a regulated manufacturing environment. This individual will perform internal audits, prepare audit reports, complete effectiveness checks, and support audit closures. They will...