MANAGER, MANUFACTURING QUALITY

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

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.