Quality Engineer, Medical Devices — Shape Global Quality

Straumann Group; Basel; On-site; CHF 90,000 - 120,000; Full time

Job summary

Straumann Group in Basel is seeking a Quality Engineer to ensure quality, compliance, and continuous improvement across products and processes throughout their lifecycle. The role collaborates with R&D, Procurement, Manufacturing, and Quality teams globally, with occasional travel to sites and suppliers.

Based in Basel, you will help identify risks, support product innovations, and ensure compliance with relevant standards and regulatory requirements.

Qualifications

• Degree in Engineering, Life Sciences, Natural Sciences, or related technical discipline.
• Experience in engineering or quality-related roles, ideally in medical devices.
• Knowledge of GD&T, ISO 8015, and regulatory standards (ISO 13485, EU MDR, FDA).

Responsibilities

• Shape product quality through design changes, NPI, PLM, and site transfers.
• Identify, assess, and mitigate product and process risks across realization.
• Support validation activities and maintain FMEAs and validation master plans.
• Lead or support CAPAs, deviations, and change control with root-cause analysis.

Skills

Quality engineering

Risk assessment

GD&T knowledge

8D / DMAIC / PDCA

Education

Engineering degree in a technical discipline

Tools

3D CAD software

Technical product documentation

Job description

Straumann Group in Basel is seeking a Quality Engineer to ensure quality, compliance, and continuous improvement across products and processes throughout their lifecycle. The role collaborates with R&D, Procurement, Manufacturing, and Quality teams globally, with occasional travel to sites and suppliers.

Based in Basel, you will help identify risks, support product innovations, and ensure compliance with relevant standards and regulatory requirements.