Medical Device Design Quality Engineer

Sterling Engineering Ltd - Ireland & Europe; Galway; Presencial; EUR 60.000 - 85.000; Jornada completa

Descripción de la vacante

Sterling Engineering Ltd in Ireland seeks a Design Assurance Engineer to support quality activities across the medical device product lifecycle. You will ensure compliance with design controls, risk management, QMS procedures, and regulatory requirements.

The role involves collaborating with cross-functional teams, customers, and suppliers to drive NPD from concept to launch. The ideal candidate has 3+ years in medical device quality assurance or design quality engineering, with experience in

Formación

• Bachelor’s degree in Engineering or related technical field.
• Experience with design controls, risk management, and quality documentation in medical devices.

Responsabilidades

• Lead quality engineering activities across new product development programmes, ensuring design control compliance.
• Develop and maintain quality documentation throughout the product development lifecycle.
• Ensure adherence to QMS, regulatory requirements, and ISO 13485 across projects.
• Manage DHF, DMR, and other essential quality documentation.
• Support risk assessments, verification and validation activities, and quality plans for pilot production and scale-up.
• Collaborate with cross-functional teams to ensure timely quality deliverables.

Conocimientos

Design controls

Risk management

Quality documentation

eQMS

Educación

Bachelor's degree in Engineering

Descripción del empleo

Sterling Engineering Ltd in Ireland seeks a Design Assurance Engineer to support quality activities across the medical device product lifecycle. You will ensure compliance with design controls, risk management, QMS procedures, and regulatory requirements.

The role involves collaborating with cross-functional teams, customers, and suppliers to drive NPD from concept to launch. The ideal candidate has 3+ years in medical device quality assurance or design quality engineering, with experience in