Senior Manager, Manufacturing Quality & Compliance

Stago Group; New Jersey; Hybrid; USD 100.000 - 130.000; Vollzeit

Zusammenfassung

The Manager, Manufacturing Quality is a visible, hands-on leader who builds a strong quality and compliance culture for DSRV Inc. and partners across Operations, Engineering, and Supply Chain to enable reliable execution and sustainable growth.

They own and advance the manufacturing quality system, act as Quality Management Representative for DSRV Inc., and Deputy MR for Stago North America, using data-driven, risk-based problem solving to prevent issues and strengthen product quality.

Qualifikationen

• Bachelor's degree in science, engineering, or related field required; master's preferred.
• 7+ years in a medical device manufacturing environment.
• 3+ years of team leadership/supervisory experience.
• Experience with ISO 13485, FDA 21 CFR 820, and ISO 14971.

Aufgaben

• Provide day-to-day quality leadership for manufacturing operations with floor presence.
• Lead QMS integration between DSRV Inc. and Stago North America.
• Drive CAPA, investigations, root-cause analysis, and nonconformance handling.
• Lead internal audits and management review inputs with a focus on risk and improvement.
• Champion Lean, continuous improvement, and readiness for audits/inspections.

Kenntnisse

Leadership

Quality mindset

Risk-based thinking

Ausbildung

Bachelor's Degree in science or engineering

Master's degree preferred

Jobbeschreibung

The Manager, Manufacturing Quality is a visible, hands-on leader who builds a strong quality and compliance culture for DSRV Inc. and partners across Operations, Engineering, and Supply Chain to enable reliable execution and sustainable growth.

They own and advance the manufacturing quality system, act as Quality Management Representative for DSRV Inc., and Deputy MR for Stago North America, using data-driven, risk-based problem solving to prevent issues and strengthen product quality.