Quality Engineer – Medical Technology (80–100% FTE)

About the role

We are seeking a Quality Engineer to join an established medical technology manufacturer in western Switzerland. The role offers real ownership over product quality, with responsibility for ensuring compliance with stringent regulatory standards and driving continuous improvement.

Key responsibilities

• Uphold the highest quality standards in a fully regulated environment (GxP, ISO 13485, FDA 21 CFR Part 820).
• Manage changes, deviations, 8‑D reports and effective corrective‑and‑preventive actions (CAPA).
• Plan and lead internal and external audits for customers, authorities and suppliers.
• Coordinate equipment qualifications and process validations (IQ, OQ, PQ).
• Own batch release activities to ensure only flawless products are shipped.
• Drive continuous improvement initiatives using Lean methodologies.

Required profile

• Technical education (HF/FH) with additional training in quality management.
• Several years of quality assurance experience in a production setting, preferably in MedTech and familiar with ISO 13485.
• Knowledge of Lean Management, Computer‑Assisted Quality (CAQ) and ERP systems.
• Fluent German and strong English communication skills; additional languages are a plus.

Required skills

• Lean Management
• CAQ systems
• ERP systems
• Regulatory standards (ISO 13485, FDA 21 CFR Part 820, GxP)