Senior Manager, Quality Compliance

Job Summary

Leading a high-performing team, the full-time Senior Manager, Quality Compliance will oversee the Quality Management System (QMS) to ensure compliance with global medical device regulations, drive continuous improvement initiatives, and foster a "Quality-first" culture within the organization.

Key Responsibilities

• Manage the holistic aspects of the QMS to ensure compliance with FDA, ISO 13485, EU MDR, and MDSAP regulations
• Serve as the primary subject matter expert during audits and prepare the organization for quality compliance to support global expansion
• Lead, mentor, and develop a team of quality professionals while collaborating with cross-functional leaders to integrate quality processes

Required Qualifications

• Bachelor's degree in engineering or a scientific discipline, or equivalent
• 10+ years of progressive experience in Quality within the medical device industry, including 5+ years in a leadership role
• Expert-level knowledge of FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971 regulations
• Proven experience leading or serving as a key SME during regulatory inspections
• Exceptional leadership skills with the ability to influence and build consensus among senior leaders