Sr Design Quality Engineer

Senior Design Quality Engineer at a global medical technology company responsible for quality assurance, design control, and document management across product lines. The role involves leading cross-functional teams, managing regulatory compliance, and mentoring quality professionals in an FDA-regulated environment.

Responsibilities

• Serve as Quality representative on cross-functional teams, applying Design Control principles to new products and process changes
• Author, review, and approve Quality System documentation including CAPAs, Design History Files, and validation protocols
• Lead risk management activities including FMEA, FMECA, and FTA development and review
• Analyze nonconformances, determine root causes, and drive corrective and preventive actions
• Perform internal and supplier quality audits; mentor and supervise quality professionals

Requirements

• Bachelor's or Master's degree in Biomedical, Electrical, or Mechanical Engineering
• 5+ years of experience in FDA-regulated medical device environments
• 3+ years of product design experience
• 2+ years of Quality Engineering in regulated settings
• Knowledge of FDA, MDSAP, PMDA, and CFDA regulations
• Proficiency in statistical analysis and applied methodologies
• Experience managing international suppliers and manufacturers