Director of Manufacturing Quality

We are looking for an exceptional Director of Manufacturing Quality to lead our quality organization and drive excellence across all aspects of our medical device manufacturing operations. This is a unique opportunity for a hands-on leader who thrives in a fast-paced, innovative manufacturing and NPI environment.

How you will make an impact as a Director of Manufacturing Quality :

The successful candidate will be responsible for ensuring production processes are well controlled and compliant, driving continuous improvement and consistent product quality.

Quality Leadership & Strategy :

• Provide strategic leadership and continuous improvement of a manufacturing-focused Quality Management System (QMS), ensuring compliance with FDA QSR GMP's and ensuring that all products, processes, and practices meet regulatory and high-quality standards
• Lead the Management Review process to evaluate QMS performance, and ensure alignment with business goals
• Facilitate risk-based, cross-functional decision-making and embed quality principles across all organizational levels
• Foster a culture of quality excellence, accountability, and continuous improvement
• Build, scale, and mentor a high-performing Quality Engineering and Quality Assurance team aligned with organizational growth and operational goals
• Establish QMS performance metrics and dashboards to monitor trends, support data-driven decisions, and enhance organizational visibility
• Administer and optimize core quality systems including, but not limited to : Corrective and Preventive Action (CAPA), Change Control, Document Control, Training, Complaint Handling, and Audits
• Prepare for and host regulatory audits from FDA, Notified Bodies, and strategic partners

Product Quality

Skills needed to be successful :

Deep knowledge of FDA QSR (21 CFR Part 820) Good Manufacturing Practices

People-focused leader with proven ability to build and develop high-performing teams

Preferred Qualifications :