Design Assurance 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

Title: Design Assurance Quality Engineer

About the Opportunity

My client are seeking an experienced Design Quality Assurance Engineer to join their team in Galway.

This is an excellent opportunity for a motivated Quality Engineer with experience in medical device design and development to play a key role in bringing innovative medical technologies from concept through to commercialisation.

Working closely with cross-functional project teams, customers and suppliers, you will provide quality leadership throughout the New Product Development (NPD) lifecycle, ensuring products meet the highest standards of safety, quality and regulatory compliance.

You will be instrumental in driving design controls, risk management, quality planning and continuous improvement, while supporting the successful launch and scale-up of new medical device products.

Key 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.

What We’re Looking For

• 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.

Desirable Skills and Experience

• Experience leading product verification and validation activities.
• Experience working with manufacturing and operations teams to develop robust manufacturing processes and work instructions.
• Previous involvement in supplier, customer, third-party or Quality Management System audits.
• Experience using an electronic Quality Management System (eQMS).
• Knowledge of probability and statistics.
• Lean or Six Sigma certification or practical experience.
• Experience supporting New Product Development and product commercialisation programmes.

The Ideal Candidate

You will be a proactive and solutions-focused Quality Engineer who enjoys working in a fast-paced, collaborative medical device manufacturing environment.

You will demonstrate:

• A strong customer-focused mindset and professional approach.
• The confidence to lead quality activities and influence cross-functional teams.
• Excellent problem-solving and technical decision-making skills.
• Flexibility, initiative and the ability to adapt to changing project requirements.
• A drive for continuous improvement and delivering high-quality outcomes.