MANAGER, MANUFACTURING QUALITY

Top Echelon Software, LLC; Budd Lake (NJ); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Top Echelon Software, LLC is seeking a Manager, Manufacturing Quality to lead a high‑performing quality organization within a medical instrumentation manufacturing environment. The role focuses on building a strong quality and compliance culture, advancing the QMS, and partnering across Operations, Engineering, and Supply Chain to enable reliable execution and continuous improvement.

The incumbent will coach and develop the quality team, own CAPA and investigations, drive product release

Formación

• Bachelor's degree in science, engineering, or related field required; Master's preferred.
• Minimum 7 years in a medical device manufacturing environment.
• Minimum 3 years of leadership/supervisory experience.
• Experience with quality systems, nonconformance, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation/qualification.
• Knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971; practical application.
• Proficient with Microsoft Office; able to learn manufacturing systems.
• ASQ certifications a plus.
• Travel up to 10% (domestic/international).

Responsabilidades

• Provide day-to-day quality leadership for manufacturing operations.
• Lead, coach, and develop Quality team members.
• Own and advance the manufacturing quality system.
• Support production issue disposition and investigations.
• Partner across Operations, Engineering, and Supply Chain.

Conocimientos

Quality leadership

QMS knowledge

CAPA investigations

Root cause analysis

Manufacturing quality

Educación

Bachelor’s in science/engineering

Master’s degree preferred

Herramientas

MS Office

Quality software

Descripción del empleo

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.