Manufacturing Quality Manager - Medical Device Leader

Top Echelon Software, LLC; Budd Lake (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Top Echelon Software, LLC is seeking a Manager, Manufacturing Quality to lead a high‑performing quality organization within a medical instrumentation manufacturing environment. The role focuses on building a strong quality and compliance culture, advancing the QMS, and partnering across Operations, Engineering, and Supply Chain to enable reliable execution and continuous improvement.

The incumbent will coach and develop the quality team, own CAPA and investigations, drive product release

Qualifications

• Bachelor's degree in science, engineering, or related field required; Master's preferred.
• Minimum 7 years in a medical device manufacturing environment.
• Minimum 3 years of leadership/supervisory experience.
• Experience with quality systems, nonconformance, CAPA, investigations, root cause analysis, product release, audits, supplier quality, and validation/qualification.
• Knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971; practical application.
• Proficient with Microsoft Office; able to learn manufacturing systems.
• ASQ certifications a plus.
• Travel up to 10% (domestic/international).

Responsibilities

• Provide day-to-day quality leadership for manufacturing operations.
• Lead, coach, and develop Quality team members.
• Own and advance the manufacturing quality system.
• Support production issue disposition and investigations.
• Partner across Operations, Engineering, and Supply Chain.

Skills

Quality leadership

QMS knowledge

CAPA investigations

Root cause analysis

Manufacturing quality

Education

Bachelor’s in science/engineering

Master’s degree preferred

Tools

MS Office

Quality software

Job description

Top Echelon Software, LLC is seeking a Manager, Manufacturing Quality to lead a high‑performing quality organization within a medical instrumentation manufacturing environment. The role focuses on building a strong quality and compliance culture, advancing the QMS, and partnering across Operations, Engineering, and Supply Chain to enable reliable execution and continuous improvement.

The incumbent will coach and develop the quality team, own CAPA and investigations, drive product release