Quality Engineer

Discover International; Deutschland; Vor Ort; EUR 55.000 - 85.000; Vollzeit

Zusammenfassung

Discover International in Berlin, Germany is seeking a Quality Engineer to support quality and compliance activities across the full product development lifecycle for regulated medical devices.

You will collaborate with R&D, Regulatory, Manufacturing and Product teams, maintain technical documentation, and contribute to audit readiness and external inspections, ensuring compliance with ISO 13485, ISO 14971, EU MDR and FDA.

Qualifikationen

• 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.

Aufgaben

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

Kenntnisse

Quality engineering

Attention to detail

Cross-functional collaboration

Ausbildung

Engineering or related field

Jobbeschreibung

Berlin, Germany An innovative global medical device company is seeking a

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