Design Quality Engineer

Responsible for ensures quality assurance, compliance, and integrity during the development, verification, validation, and sustaining engineering.
What You'll Do:Partner with cross-functional teams to verify design requirements, validate product performance, and ensure full compliance with ISO 13485, MDR, and QMSR.Lead risk assessment activities, review V&V protocols/reports, manage Engineering Change Notices (ECNs), and apply rigorous statistical methods to design data.Create, test, and implement test method validations (TMV) for new and existing medical products.Drive complaint investigations, identify design quality system gaps, and foster a strong culture of quality across the organization.
What You Bring:
Education: Bachelor’s degree in Engineering or Science (Industrial, Chemical, Materials, Mechanical, Electrical, Electronic, or related field).Experience: 3+ years of design or manufacturing experience within the Medical Devices industry.Standards Expertise: Strong working knowledge of ISO 13485, EU MDR, and FDA/QMSR standards.Languages: English proficiency (B2 minimum).
Skills:
Excellent attention to detail and ability to consistently meet high standards of quality.Good organization and time management skills.Ability to work simultaneously on multiple projects.