Design Quality Engineer

About the role

The Design Quality Engineer ensures quality assurance, compliance, and integrity throughout product development, verification, validation, and sustaining engineering for medical devices.

Key responsibilities

• Partner with cross‑functional teams to verify design requirements, validate product performance, and ensure compliance with ISO 13485, MDR, and QMSR.
• Lead risk assessment activities, review V&V protocols and reports, manage Engineering Change Notices, and apply statistical methods to design data.
• Create, test, and implement test method validations for new and existing medical products.
• Drive complaint investigations, identify design quality system gaps, and promote a strong quality culture.

Required profile

• Bachelor’s degree in Engineering or Science (Industrial, Chemical, Materials, Mechanical, Electrical, Electronic, or related).
• 3+ years of design or manufacturing experience in the medical devices industry.
• Strong working knowledge of ISO 13485, EU MDR, and FDA/QMSR standards.
• English proficiency at minimum B2 level.

Required skills

• ISO 13485 standard
• EU MDR regulation
• FDA QMSR requirements
• Risk assessment methodology
• Statistical analysis of design data