Senior Medical Device Design Quality Engineer

Life Science Recruitment; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

Life Science Recruitment in Galway seeks an experienced Design Quality Assurance Engineer to join our client’s team in Galway, focusing on medical device design and development from concept through to commercialisation.

You will drive design controls, risk management, quality planning and continuous improvement, supporting the successful launch and scale-up of new medical device products while ensuring compliance with ISO 13485, QSR and related regulations.

Qualifications

• Bachelor’s degree in Engineering or a related discipline.
• Minimum of 3 years’ experience in medical device design and development and/or Quality Assurance.
• Strong understanding of design controls, risk management and quality systems within the medical device industry.
• Familiarity with ISO 13485, FDA Quality System Regulations (QSR) and relevant medical device regulations.

Responsibilities

• Provide Quality Engineering leadership and support across New Product Development projects, ensuring quality requirements are embedded throughout the product lifecycle.
• Lead and support the preparation and maintenance of quality documentation, including Design History Files (DHF), Device Master Records (DMR), design controls and risk management documentation.
• Ensure compliance with the company's Quality Management System, applicable medical device regulations and industry standards.
• Lead design risk assessments to evaluate product functionality, safety and performance.
• Support and oversee CAPA, change control, document control, product release and internal and supplier audit activities.
• Lead and contribute to product verification and validation activities, ensuring appropriate planning, execution and documentation.
• Support pilot production, manufacturing process development and production scale-up activities.
• Work collaboratively with customers, suppliers and internal stakeholders to resolve technical and quality-related issues.
• Support supplier qualification, supplier audits and ongoing supplier quality activities.

Skills

Quality leadership

Design controls

Risk management

ISO 13485 familiarity

QSR knowledge

Education

Bachelor’s degree in Engineering

Job description

Life Science Recruitment in Galway seeks an experienced Design Quality Assurance Engineer to join our client’s team in Galway, focusing on medical device design and development from concept through to commercialisation.

You will drive design controls, risk management, quality planning and continuous improvement, supporting the successful launch and scale-up of new medical device products while ensuring compliance with ISO 13485, QSR and related regulations.