Design Quality Engineer

About the role

Moog Medical seeks a Design Quality Engineer responsible for quality assurance, compliance, and integrity during development, verification, validation, and sustaining engineering.

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 (ECNs), and apply 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 culture of quality across the organization.

Requirements

• Bachelor’s degree in Engineering or Science, such as Industrial, Chemical, Materials, Mechanical, Electrical, Electronic, or a related field.
• 3+ years of design or manufacturing experience within the Medical Devices industry.
• Strong working knowledge of ISO 13485, EU MDR, and FDA/QMSR standards.
• English proficiency at B2 minimum.
• Excellent attention to detail and ability to consistently meet high standards of quality.
• Good organization and time management skills, with the ability to work simultaneously on multiple projects.

Datos clave

• Location: Alajuela, Costa Rica.
• Requires a bachelor’s degree in Engineering or Science, or a related field.
• Requires 3+ years of design or manufacturing experience within the Medical Devices industry.
• Requires English proficiency at B2 minimum.