Manufacturing Quality Leader, Medical Devices

Sora Resource Group; Budd Lake (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Sora Resource Group is seeking a Manager, Manufacturing Quality to lead the quality system for a medical device manufacturing operation. The role focuses on building a strong culture of quality and compliance, developing personnel, and partnering with Operations, Engineering, and Supply Chain to enable reliable execution and sustainable growth.

The position requires overseeing day-to-day quality leadership on the manufacturing floor, driving CAPA investigations, product release decisions, and

Qualifications

• Bachelor's degree required 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 required.
• 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, and ISO 14971 risk management principles.

Responsibilities

• Own and advance the manufacturing quality system and lead development of quality team members.
• Provide day-to-day Quality leadership for manufacturing operations, including floor presence and timely resolution of production issues.
• Coach and develop Quality team members through clear priorities and regular feedback.
• Escalation support, disposition decisions, QMS training, and collaboration across Operations, Engineering, and Supply Chain.

Skills

Quality leadership

CAPA & investigations

Root cause analysis

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Master's degree preferred

Tools

Microsoft Office

Quality systems knowledge

Job description

Sora Resource Group is seeking a Manager, Manufacturing Quality to lead the quality system for a medical device manufacturing operation. The role focuses on building a strong culture of quality and compliance, developing personnel, and partnering with Operations, Engineering, and Supply Chain to enable reliable execution and sustainable growth.

The position requires overseeing day-to-day quality leadership on the manufacturing floor, driving CAPA investigations, product release decisions, and