MANAGER, MANUFACTURING QUALITY

6 Degrees Search; Budd Lake (NJ); On-site; USD 120,000 - 170,000; Full time

Job summary

Unknown is seeking a Manager, Manufacturing Quality to lead a medical instrument manufacturing quality function in New Jersey. You will own the QMS, oversee CAPA, investigations, and product release, and partner across Operations, Engineering, and Supply Chain.

The role requires building a strong quality culture, developing people, and driving continuous improvement to ensure reliable execution, customer confidence, and growth. Travel up to 10% is expected.

Qualifications

• Bachelor's degree in science, engineering, or related field required.
• Master's degree preferred for advanced roles.
• 7+ years in medical device manufacturing.
• 3+ years in team leadership/supervisory roles.
• Knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971; practical application.

Responsibilities

• Own and advance the manufacturing quality system.
• Lead, coach, and develop Quality team members.
• Provide day-to-day Quality leadership for manufacturing operations.
• Escalation support, disposition decisions, QMS training, and issue resolution.
• Travel up to 10% (domestic and possibly international).

Skills

Leadership

Quality systems

Root cause analysis

Investigations

Audits

Regulatory knowledge

Education

Bachelor's degree in science/engineering

Master's degree preferred

Tools

Microsoft Office

Quality management systems

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.