Senior Manufacturing Quality Leader – Medical Devices

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

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