Quality Engineer 

Berlin, Germany 

An innovative global medical device company is seeking a Quality Engineer to support quality and compliance activities across the full product development lifecycle for complex regulated medical devices.

This is an excellent opportunity to join a highly collaborative team working on technically advanced products with real patient impact.

Key Responsibilities

• Review and maintain technical documentation across design, risk management, verification/validation, clinical, and post-market activities

• Ensure compliance with global medical device standards and regulations (ISO 13485, ISO 14971, EU MDR, FDA)

• Support design control, change control, and quality processes throughout development

• Partner cross-functionally with R&D, Regulatory, Manufacturing, and Product teams

• Contribute to audit readiness and support external inspections / notified body interactions

Ideal Background

• Degree in Engineering, Biomedical Engineering, Life Sciences, or related field

• Experience in medical device quality, design assurance, or technical documentation

• Strong knowledge of medical device regulations and quality standards

• Experience supporting product development within regulated environments

• Detail-oriented, proactive, and comfortable managing multiple priorities

Why Join?

• Work on innovative, high-impact medical technologies

• Broad exposure across the full product lifecycle

• Collaborative and fast-paced global environment

• Strong opportunity for growth and development