Quality Engineering Manager

📋 Description

• Lead Quality Engineering support for assigned product portfolios and production lines
• Partner with Production, Manufacturing Engineering, and Industrial Engineering to embed quality in processes
• Own manufacturing quality metrics: yield, scrap, productivity, and related losses
• Own and advance inspection strategies: in-process and final inspection, sampling plans, acceptance criteria
• Drive continuous improvement of inspection systems, test methods, process monitoring, and digital quality tools
• Apply Lean and Six Sigma methodologies to improve yield, reduce waste, and enhance process capability

🎯 Requirements

• Bachelor's degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related)
• 5+ years of experience in Quality Engineering or Manufacturing Engineering in medical devices
• 1+ year of leadership/people management experience
• Working knowledge of FDA QSR and ISO 13485 in manufacturing
• Experience with data systems (PowerBI or Tableau), statistical analysis, and design of experiments
• CQE certification or training

🎁 Benefits

• Collaborative, learning-focused team environment
• Opportunity to help treat serious diseases
• Generous benefits: medical, dental, vision, life, AD&D, disability
• 401(k) with employer match and paid parental leave
• Eleven paid holidays and vacation
• Paid sick time per applicable law