Manufacturing Quality Manager - Process Excellence

Diagnostica Stago; Parsippany-Troy Hills (NJ); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Medical benefits

401(k)

PTO

Job summary

Diagnostica Stago seeks a Manager, Manufacturing Quality to lead a hands-on quality culture on the production floor, partner with Operations, R&D and Supply Chain, and own the QMS for DSRV, Inc. You will ensure product quality, drive CAPA, and prepare for regulatory inspections in a fast‑paced manufacturing setting.

The role emphasizes data‑driven decisions, risk‑based thinking, and continuous improvement with a focus on reliable execution and customer confidence.

Qualifications

• Bachelor's degree in science, engineering, or related field; master’s preferred.
• Minimum 7 years in a medical device manufacturing environment.
• Minimum 3 years leading teams/supervising people.
• Solid knowledge of ISO 13485, FDA 21 CFR 820, ISO 14971 and risk management.

Responsibilities

• Provide day-to-day Quality leadership for manufacturing operations with floor presence and issue resolution.
• Manage QMS integration between DSRV Inc. and Stago North America.
• Lead investigations, CAPA, audits, and supplier quality activities.
• Drive continuous improvement, risk reduction, and readiness for audits and inspections.

Skills

Leadership

Quality systems

Risk management

Education

Bachelor's Degree in science/engineering

Master's degree preferred

Job description

Diagnostica Stago seeks a Manager, Manufacturing Quality to lead a hands-on quality culture on the production floor, partner with Operations, R&D and Supply Chain, and own the QMS for DSRV, Inc. You will ensure product quality, drive CAPA, and prepare for regulatory inspections in a fast‑paced manufacturing setting.

The role emphasizes data‑driven decisions, risk‑based thinking, and continuous improvement with a focus on reliable execution and customer confidence.