MANAGER, MANUFACTURING QUALITY

Zaddy Solutions; Budd Lake (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Zaddy Solutions, based in New Jersey, seeks a Manager of Manufacturing Quality to lead a hands-on quality function across manufacturing operations, engineering, and supply chain. You will own and advance the manufacturing quality system, coach a growing quality team, drive CAPA and investigations, and partner to ensure compliant, reliable production and seamless product releases.

This role requires strong regulatory knowledge, strategic mindset, and the ability to develop people through feedback

Qualifications

• Bachelor's degree in science, engineering, or related field required; Master's preferred.
• 7+ years in medical device manufacturing; 3+ years in leadership roles.
• Experience with nonconformance, CAPA, investigations, root cause analysis, and product release.
• Working knowledge of ISO 13485, FDA 21 CFR 820 (QMSR), and ISO 14971 risk management.
• Willingness to travel up to 10% (domestic and possibly international).

Responsibilities

• Provide day-to-day quality leadership for manufacturing operations, including floor presence and issue resolution.
• Own and advance the manufacturing quality system and drive a strong quality culture across Operations, Engineering and Supply Chain.
• Lead, coach, and develop Quality team members with clear priorities and growth opportunities.
• Lead investigations, CAPA, audits, supplier quality, and validation/qualification activities as required.

Skills

Leadership

Quality leadership

CAPA investigations

Root cause analysis

Quality system knowledge

Audits

Education

Bachelor's degree in science, engineering, or related field

Master's degree preferred

Tools

MS 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.