MANAGER, MANUFACTURING QUALITY

Location: Budd Lake, NJ | Schedule: full-time, on-site

Overview

A manufacturer of medical instrumentation is seeking a Manager, Manufacturing Quality to serve as a visible, hands-on leader who builds a strong quality and compliance culture, develops people, strengthens manufacturing controls, and partners across Operations, Engineering, and Supply Chain. This role shapes how quality enables reliable execution, continuous improvement, customer confidence, and sustainable growth, with ownership of the manufacturing quality system and leadership of quality team members.

What you'll do

• Own and advance the manufacturing quality system, including leading and developing quality team members
• Lead, coach, and develop Quality team members through clear priorities, regular feedback, effective delegation, and meaningful growth opportunities
• Provide day-to-day Quality leadership for manufacturing operations, including floor presence, escalation support, and disposition decisions
• Deliver QMS training and ensure timely resolution of production issues
• Partner across Operations, Engineering, and Supply Chain to strengthen manufacturing controls

Required qualifications

• Bachelor's Degree in science, engineering, or related field
• Minimum 7 years of related experience in a medical device manufacturing environment
• Minimum 3 years' team leadership/supervisory experience
• Demonstrated experience with manufacturing quality systems, nonconformance, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation or qualification activities
• Working knowledge of applicable quality system standards and requirements, such as ISO 13485, FDA 21 CFR 820 (QMSR), and ISO 14971 risk management principles, with the ability to apply requirements in a practical manufacturing environment
• Proficiency with Microsoft Office applications and the ability to learn and use quality and manufacturing systems
• 10% travel, both domestically and possibly internationally

Preferred qualifications

• Master's degree
• ASQ certifications a plus

Why this role

This is a visible, hands-on leadership opportunity to shape how quality enables reliable execution, continuous improvement, customer confidence, and sustainable growth.