MANAGER, MANUFACTURING QUALITY

Top Echelon LLC; Budd Lake (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Top Echelon LLC seeks a Manager, Manufacturing Quality to lead the quality organization on the manufacturing floor, driving a culture of compliance and continuous improvement across Operations, Engineering and Supply Chain.

You will own the manufacturing quality system, mentor the quality team, manage CAPA, audits, and product releases, and ensure timely resolution of production issues while enabling reliable execution and customer confidence.

Qualifications

• Bachelor's degree in science, engineering or related field required.
• Minimum 7 years of related experience in a medical device manufacturing environment.
• Minimum 3 years’ team leadership/supervisory experience.
• Experience with manufacturing quality systems, nonconformance, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation activities.
• Working knowledge of ISO 13485, FDA 21 CFR 820 (QMSR) and ISO 14971 risk management.
• Proficiency with Microsoft Office applications.

Responsibilities

• Own and advance the manufacturing quality system and lead the quality team.
• Provide day-to-day quality leadership for manufacturing operations on the floor.
• Lead escalation, disposition decisions, QMS training and timely resolution of production issues.
• Partner across Operations, Engineering and Supply Chain to strengthen controls and continuous improvement.

Skills

Leadership

Quality systems

CAPA

Investigations

Root cause analysis

Audits

QMS training

Education

Bachelor's Degree in science, engineering, or related field

Master's degree preferred

Tools

Microsoft Office

Job description

Hiring company is a manufacturer of medical instrumentation. The Manager, Manufacturing Quality is 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 offers the opportunity to shape how quality enables reliable execution, continuous improvement, customer confidence, and sustainable growth. The position will own and advance the manufacturing quality system, including leading and development of 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, disposition decisions, QMS training, and timely resolution of production issues.

Education and/or Experience:

• Bachelor's Degree in science, engineering, or related field is required. Master's degree preferred.
• Minimum 7 years of related experience in a medical device manufacturing environment required.
• Minimum 3 years’ team leadership/supervisory experience required.
• Demonstrated experience with manufacturing quality systems, nonconformance, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation or qualification activities required.
• Must possess working knowledge of applicable quality system standards and requirements, such as ISO 13485, FDA 21 CFR 820 (QMSR), and ISO 14971 risk management principles and 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.
• ASQ certifications a plus.
• 10% travel. Must be able to travel both domestically and possibly internationally.