MANAGER, MANUFACTURING QUALITY

Ashton North LLC; Budd Lake (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Ashton North LLC seeks a Manager, Manufacturing Quality to lead and develop a high-performing quality team within a medical device manufacturing environment. You will champion a culture of quality, drive continuous improvement, and partner across Operations, Engineering, and Supply Chain to ensure reliable execution and customer confidence.

Responsibilities include owning the quality system, mentoring staff, leading investigations, and ensuring product release and compliance with ISO 13485, FDA

Qualifications

• Proven leadership and team development experience.
• Strong knowledge of manufacturing quality systems and QMS controls.
• Experience with CAPA, investigations, root cause analysis, and audits.

Responsibilities

• Provide day-to-day Quality leadership for manufacturing operations.
• Coach and develop Quality team members with clear priorities and feedback.
• Lead QMS training and ensure timely resolution of production issues.
• Ensure compliance with ISO 13485, FDA 21 CFR 820, and ISO 14971.

Education

Bachelor's degree in science/engineering

Master's degree preferred

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.