Quality Engineer

📋 Description

• Create, revise and update quality processes and documentation
• Develop SOPs, work instructions, specifications
• Lead compliance activities: CAPA, audits, non-conformances
• Coordinate internal/external audits (FDA, Notified Body, HIPAA)
• Participate in CAPA, deviation investigations and reporting
• Perform risk assessments (FMEA, FTA) with cross-functional teams

🎯 Requirements

• B.S./equivalent in science or engineering
• 2–5 years in quality processes in regulated env.
• ASQ CQE/CMQ/OE preferred
• ISO14971 experience
• MS Word, Excel, PowerPoint
• Strong technical writing and communication

🎁 Benefits

• Medical, dental, vision, life and disability plans
• Fertility care benefits and free testing for employees
• Pregnancy/baby bonding leave, 401k, commuter benefits
• Employee referral program