Senior Supplier Quality Auditor (ISO 13485, German/English)

RED Global; Zürich; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

RED Global is seeking a Certified Lead Auditor for a Swiss-based operation to support post-acquisition QMS integration and supplier quality improvements. The consultant will conduct supplier audits, identify compliance gaps, and drive remediation to closure in a regulated medical-device environment.

Requirements include Lead Auditor certification (ISO 13485 preferred), strong ISO 13485:2016 knowledge, and fluent German and English.

Qualifikationen

• Must have strong Supplier Quality experience in medical devices or regulated industries.
• Proven experience with M&A/post-acquisition integration or QMS remediation.
• Lead Auditor certification mandatory; ISO 13485 Lead Auditor preferred.
• Solid knowledge of ISO 13485:2016.
• Familiarity with EU MDR 2017/745 and Swiss medical-device requirements desirable.
• Knowledge of ISO 14971, ISO 19011 and/or MDSAP advantageous.
• Extensive experience with supplier audits, CAPA, risk management, non-conformances and supplier qualification.
• Fluent German and English are mandatory.
• Willingness to work onsite regularly in Switzerland.

Aufgaben

• Support post-acquisition QMS integration activities in a Swiss operation.
• Assess and improve Supplier Quality processes and CAPA programs.
• Conduct supplier audits and identify compliance gaps; drive remediation to closure.
• Collaborate with cross-functional teams during integration and continuous improvement.

Kenntnisse

Supplier Quality

Post-acq integration

M&A remediation

Lead Auditor certification

ISO 13485:2016

EU MDR & Swissmedic knowledge

ISO 14971 / ISO 19011 / MDSAP

Auditing & CAPA

Risk management

Fluent German

Fluent English

Onsite in Switzerland

Jobbeschreibung

RED Global is seeking a Certified Lead Auditor for a Swiss-based operation to support post-acquisition QMS integration and supplier quality improvements. The consultant will conduct supplier audits, identify compliance gaps, and drive remediation to closure in a regulated medical-device environment.

Requirements include Lead Auditor certification (ISO 13485 preferred), strong ISO 13485:2016 knowledge, and fluent German and English.