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