Quality & Compliance Lead, Medical Device Manufacturing

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

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