Quality Engineer

📋 Description

• Support Quality Management System across product development, manufacturing, supplier operations
• Investigate issues and drive effective, compliant solutions with cross-functional teams.
• Contribute to CAPA, audits, supplier quality, change management, and regulatory readiness.
• Collaborate with Engineering, Operations, Regulatory Affairs, and external suppliers to improve

🎯 Requirements

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related technical discipline
• 5–8 years in Quality Engineering/QA/Quality Systems in medical device industry
• Knowledge of FDA QSR, ISO 13485, risk management principles, and medical device quality requirements
• Experience with investigations, CAPA, supplier quality, and change management
• Cross-functional collaboration across Engineering, Manufacturing, Operations, Regulatory Affairs
• Strong problem-solving, analytical, organizational, and communication skills

🎁 Benefits

• Base salary $95,000–$105,000 annually
• Comprehensive benefits package beginning Day 1
• Medical, dental, and vision insurance
• Life insurance coverage
• 401(k) plan with employer matching
• Contribution to quality, compliance, innovation, and continuous improvement in a medical device