MANAGER, MANUFACTURING QUALITY

Htprof; Budd Lake (NJ); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Htprof is seeking a hands-on Manager, Manufacturing Quality to lead a quality and compliance culture across Operations, Engineering, and Supply Chain. You will own and advance the manufacturing quality system, including leading and developing quality team members, providing day-to-day quality leadership on the manufacturing floor, and driving timely issue resolution.

The role requires a Bachelor's in science or engineering (Master's preferred), 7+ years in medical device manufacturing, 3+ years

Qualifications

• 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.
• Minimum 3 years’ team leadership/supervisory experience.
• Demonstrated experience with manufacturing quality systems, nonconformance, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation or qualification activities.
• Must possess working knowledge of 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.

Responsibilities

• Own and advance the manufacturing quality system and lead quality team members.
• Provide day-to-day quality leadership for manufacturing operations on the floor.
• Coach, develop, and provide feedback and growth opportunities to the quality team.
• Coordinate with Operations, Engineering, and Supply Chain to resolve production issues.
• Ensure compliance with ISO 13485, FDA 21 CFR 820, and ISO 14971 risk management principles.

Skills

Team leadership

Quality leadership

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in science or engineering

Master's degree preferred

Tools

Microsoft Office

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.