MANAGER, MANUFACTURING QUALITY

Tom Trese Networking LLC; Budd Lake (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Tom Trese Networking LLC is seeking a Manager, Manufacturing Quality to lead a quality culture in a medical device manufacturing environment. You will drive compliance, continuous improvement, and reliable execution across Operations, Engineering, and Supply Chain.

Responsibilities include developing people, leading the quality team on the floor, and ensuring timely disposition decisions, CAPA, and QMS training, with travel up to 10% as needed domestically or internationally.

Qualifications

• Bachelor's degree in science, engineering, or related field; Master's preferred.
• 7+ years in a medical device manufacturing environment.
• 3+ years of team leadership/supervisory experience.
• Experience with manufacturing quality systems, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation/qualification.
• Knowledge of ISO 13485, FDA 21 CFR 820, and ISO 14971 risk management; apply to manufacturing.
• Proficiency with Microsoft Office; ability to learn quality and manufacturing systems.
• ASQ certifications a plus.
• Travel ~10%; domestic and possibly international.

Responsibilities

• Lead, coach, and develop Quality team members through clear priorities and growth.
• Provide day-to-day quality leadership for manufacturing operations and floor presence.
• Manage escalation support, disposition decisions, and QMS training.
• Drive timely resolution of production issues and compliance with quality systems.

Skills

Quality systems

CAPA investigations

Root cause analysis

Audits

MS Office

ASQ certifications

Travel readiness

Education

Bachelor's degree in science/engineering

Master's degree preferred

Tools

Quality management systems software

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.