Lead Auditor

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

One of our clients in the pharmaceutical sector is currently looking for Certified Lead Auditor to join the team.

Duration: 06 months Contract

Languages: German and English

Role - Supplier Quality (certified Lead Auditor)

A global medical-device organization is seeking an experienced Supplier Quality Consultant to support post-acquisition M&A Quality integration activities at a Swiss-based operation.

The consultant will assess and improve Supplier Quality processes, support QMS integration, conduct supplier audits, identify compliance gaps, and drive remediation activities through to closure.

Required

• Strong Supplier Quality experience in medical devices or another regulated industry.
• Proven M&A / post-acquisition integration or QMS remediation experience.
• Lead Auditor certification – mandatory, ideally ISO 13485 Lead Auditor.
• Strong working knowledge of ISO 13485:2016.
• Knowledge of EU MDR 2017/745 and Swiss medical-device requirements (MedDO/MepV / Swissmedic) desirable.
• Knowledge of ISO 14971, ISO 19011 and/or MDSAP advantageous.
• Strong experience with supplier audits, CAPA, risk management, non-conformances, and supplier qualification.
• Fluent German and English – mandatory.
• Comfortable working independently with regular onsite presence in Switzerland.