Manufacturing Quality Manager – Medical Devices

Calqulate Metrics Ltd; Budd Lake (NJ); Vor Ort; USD 120.000 - 150.000; Vollzeit

Zusammenfassung

Calqulate Metrics Ltd seeks a hands‑on Manager, Manufacturing Quality to lead our quality organization in a medical instrumentation environment. You will own the quality system, drive CAPA, investigations, and product releases, and partner with Operations, Engineering, and Supply Chain to sustain compliance and growth.

You will develop quality staff, ensure training, and provide floor support for manufacturing operations, with travel up to 10% to support audits and supplier quality activities.

Qualifikationen

• Bachelor's degree in science, engineering or related field required.
• Minimum 7 years of medical device manufacturing experience.
• Minimum 3 years’ supervisory experience.
• Experience with quality systems, nonconformance, CAPA and investigations.
• Knowledge of ISO 13485, FDA 21 CFR 820 and ISO 14971 is required.
• Proficiency with MS Office; ASQ certifications a plus.
• Travel up to 10% domestically or internationally.

Aufgaben

• Own and advance the manufacturing quality system.
• Provide day‑to‑day quality leadership for manufacturing operations.
• Lead, coach and develop Quality team members with clear priorities and growth opportunities.

Kenntnisse

Quality systems

CAPA

Investigations

Root cause analysis

Product release

Audits

Supplier quality

Validation/qualification

MS Office

Ausbildung

Bachelor's Degree in science, engineering, or related field

Master's degree preferred

Jobbeschreibung

Calqulate Metrics Ltd seeks a hands‑on Manager, Manufacturing Quality to lead our quality organization in a medical instrumentation environment. You will own the quality system, drive CAPA, investigations, and product releases, and partner with Operations, Engineering, and Supply Chain to sustain compliance and growth.

You will develop quality staff, ensure training, and provide floor support for manufacturing operations, with travel up to 10% to support audits and supplier quality activities.