MANAGER, MANUFACTURING QUALITY

RNInk; Budd Lake (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

RNInk is seeking a Manager, Manufacturing Quality who will be a visible, hands‑on leader driving a strong quality culture in a medical device environment. You will own and advance the quality system, develop team members, and provide day‑to‑day leadership for manufacturing operations on the factory floor.

You will coach quality staff, prioritize effectively, and collaborate with Operations, Engineering, and Supply Chain to resolve production issues and ensure compliant product release.

Qualifications

• Bachelor’s degree in science, engineering, or related field required; Master’s preferred.
• Minimum 7 years of related experience in a medical device manufacturing environment.
• Minimum 3 years’ team leadership/supervisory experience.
• Experience with manufacturing quality systems, nonconformance, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation/qualification.
• Working knowledge of ISO 13485, FDA 21 CFR 820 (QMSR), ISO 14971 risk management principles.

Responsibilities

• Provide day‑to‑day Quality leadership for manufacturing operations, including floor presence and issue escalation.
• Lead, coach, and develop Quality team members through clear priorities and growth opportunities.
• Partner across Operations, Engineering, and Supply Chain to strengthen controls and compliance.
• Oversee QMS training and timely resolution of production issues.
• Ensure compliance with quality system standards and regulatory requirements.

Skills

Quality leadership

Team development

Root cause analysis

CAPA investigations

Audits & compliance

QMS training

Travel readiness

Education

Bachelor’s degree in science/engineering or related field

Master’s degree preferred

Tools

ASQ certifications

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.