Senior Manager, Quality Engineering

Job Summary

A company is looking for a Senior Manager, Device Quality Engineering.

Key Responsibilities

• Lead the global strategy for software quality and design excellence, ensuring compliance with medical device regulations
• Oversee the end-to-end design control process within the Software Development Lifecycle (SDLC) and manage the Quality Management System (QMS)
• Collaborate with cross-functional teams to provide technical guidance and ensure successful regulatory submissions

Required Qualifications

• Bachelor's degree in Software Engineering, Computer Science, Biomedical Engineering, or a related field; Master's degree or MBA preferred
• 12+ years of experience in quality engineering or product development within the medical device industry
• 3-5 years of experience in a formal management or leadership role
• Preferred certifications include ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE), Certified Software Quality Engineer (CSQE), or Six Sigma Black Belt