Quality Engineer

headcount | recruitment driven by science; Zug; Vor Ort; CHF 90.000 - 120.000; Teilzeit

Zusammenfassung

headcount is seeking a hands-on Quality Engineer in Zurich to collaborate with Production and Manufacturing. The role focuses on on-floor quality issues and ensuring effective resolutions within a regulated medical device environment.

The candidate will own CAPAs and NCs, perform root-cause analyses, and support change controls and process improvements while ensuring ISO 13485 compliance.

Qualifikationen

• 3+ years of Quality Engineering in medical devices.
• Hands-on CAPA, NCs and root-cause investigations.
• Experience in a production/manufacturing environment.
• Knowledge of ISO 13485 and QMS.
• Experience with risk management, change control or process validation.
• German fluent and good English.

Aufgaben

• Own and manage CAPAs, non-conformances (NCs) and deviation investigations.
• Perform root-cause analysis and implement corrective/preventive actions.
• Provide hands-on Quality Engineering support on the production floor.
• Support change controls, risk assessments and process improvements.
• Review and disposition non-conforming materials/products.
• Work closely with Production, Manufacturing Engineering and Operations.
• Support process validation/qualification and audit activities.
• Ensure compliance with ISO 13485 and internal QMS requirements.

Kenntnisse

CAPA management

Root-cause analysis

Production floor

ISO 13485

QMS knowledge

Risk management

Change control

Process validation

German fluent

English good

Jobbeschreibung

Contract: 6 months; potential FTE conversion

We are supporting our client in Zurich looking for a hands-on Quality Engineer to work closely with Production and Manufacturing. The role has a strong shop-floor focus, taking ownership of quality issues and ensuring effective resolution within a regulated manufacturing environment.

Key Responsibilities

• Own and manage CAPAs, non-conformances (NCs) and deviation investigations.
• Perform root-cause analysis and implement corrective/preventive actions.
• Provide hands-on Quality Engineering support on the production floor.
• Support change controls, risk assessments and process improvements.
• Review and disposition non-conforming materials/products.
• Work closely with Production, Manufacturing Engineering and Operations.
• Support process validation/qualification and audit activities.
• Ensure compliance with ISO 13485 and internal QMS requirements

Your Background

• 3+ years' Quality Engineering experience within medical devices.
• Strong hands-on experience with CAPA, NCs and root-cause investigations.
• Experience working directly within a production/manufacturing environment.
• Good knowledge of ISO 13485 and medical device QMS.
• Experience with risk management, change control and/or process validation.
• Native/fluent German and good English.
• Experience with medical device assembly, packaging or manufacturing processes is advantageous.