Senior Manufacturing Quality Lead - Medical Devices On-Site

Software Placement Group; Budd Lake (NJ); Presencial; USD 120.000 - 165.000; Jornada completa

Descripción de la vacante

Software Placement Group in Budd Lake, NJ is seeking a Manager, Manufacturing Quality to lead a hands-on quality program across manufacturing operations. You will own the QMS, mentor the quality team, and partner with Operations, Engineering, and Supply Chain to enable reliable execution and continuous improvement.

The role requires strong knowledge of medical device quality systems, CAPA, audits, and risk management, with 7+ years in the field and 3+ years of leadership.

Formación

• Bachelor's degree in science, engineering, or related field.
• 7+ years in a medical device manufacturing environment.
• 3+ years' leadership/supervisory experience.
• Experience with manufacturing quality systems, CAPA, investigations, root cause analysis, and audits.
• Knowledge of ISO 13485, FDA 21 CFR 820, and ISO 14971 is preferred.

Responsabilidades

• Own and advance the manufacturing quality system and lead the quality team.
• Provide day-to-day Quality leadership for manufacturing operations.
• Deliver QMS training and ensure timely resolution of production issues.
• Partner across Operations, Engineering, and Supply Chain to strengthen controls.

Conocimientos

Quality leadership

People development

Cross-functional collaboration

Leadership

Mentoring

Educación

Bachelor's degree in science/engineering

Master's degree

Herramientas

Microsoft Office

Descripción del empleo

Software Placement Group in Budd Lake, NJ is seeking a Manager, Manufacturing Quality to lead a hands-on quality program across manufacturing operations. You will own the QMS, mentor the quality team, and partner with Operations, Engineering, and Supply Chain to enable reliable execution and continuous improvement.

The role requires strong knowledge of medical device quality systems, CAPA, audits, and risk management, with 7+ years in the field and 3+ years of leadership.