Quality Engineer (80–100%)

About the role

We are seeking a proactive Quality Engineer to join an established medical-technology manufacturer in western Switzerland. Working at 80-100 % capacity, you will have real ownership over product quality, influencing processes and ensuring compliance in a highly regulated environment.

Key responsibilities

• Maintain the highest quality standards under GxP, ISO 13485 and FDA 21 CFR Part 820 regulations.
• Manage changes, deviations, 8-D reports and drive 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, guaranteeing only flawless products advance.
• Promote continuous improvement 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 ISO 13485 environments.
• Familiarity with Lean Management, Computer-Aided Quality (CAQ) and ERP systems.
• Fluent German and strong English communication skills.

Required skills

• GxP compliance
• ISO 13485
• FDA 21 CFR Part 820
• 8-D problem-solving
• CAPA implementation
• IQ/OQ/PQ validation
• Lean Management
• CAQ tools
• ERP systems