Principal Quality Engineer

📋 Description

• Lead cross-functional CI initiatives to reduce cost of poor quality.
• Architect scalable Quality Engineering systems to prevent defects.
• Collaborate with Manufacturing, IE, Ops, and R&D to embed quality in processes.
• Develop CTQ flowdowns aligning product requirements with inspection strategies.
• Drive quality monitoring via predictive analytics, SPC, and automated visuals.

🎯 Requirements

• Bachelor's degree in Engineering; advanced degree preferred.
• 7+ years in Quality Engineering, CI, or Manufacturing in medical devices.
• ASQ CQE, CSSBB, or equivalent certification preferred.
• Lean Six Sigma, CTQ deployment, cost of quality reduction.
• Knowledge of FDA QSR and ISO 13485 in manufacturing.
• Strong cross-functional leadership and communication skills.

🎁 Benefits

• Collaborative environment with learning and rewards.
• Work on innovative therapies.
• Comprehensive benefits: health, dental, vision, 401(k).
• Paid parental leave, holidays, vacation, and sick time.