Senior Director, Quality Engineering

About the role

Lead the Quality Engineering function for new product introduction, lifecycle management, and continuous improvement in a fast‑paced medical device manufacturing environment. Partner with cross‑functional teams to deliver solutions that ensure compliance and enhance patient outcomes.

Key responsibilities

• Plan, prioritize and direct strategic programs using Six Sigma and LEAN methods, aligning with compliance standards.
• Identify risks, develop mitigation strategies, and resolve complex issues with cross‑functional groups.
• Provide technical guidance on root‑cause investigations, corrective actions, and product/process changes across multiple product lines.
• Optimize quality engineering processes, define core competencies, and drive standardized programs with network and COE teams.
• Lead talent development, succession planning, and audit engagement, delivering technical expertise and effective issue resolution.

Required profile

• Bachelor’s degree in a related field with at least 10 years of engineering and leadership experience in the medical device industry.
• Proven track record managing technical/engineering disciplines and interacting with regulators and notified bodies.
• Experience influencing global teams and delivering results in a dynamic environment.

Required skills

• Six Sigma, LEAN methodologies
• Root‑cause analysis, FMEA, design of experiments, process capability studies
• Statistical process control, industrial statistical methods
• Microsoft Office Suite and related quality systems
• Knowledge of domestic and international regulatory requirements