Design Assurance Engineer - Medical Devices & Quality

Oxford Global Resources; Galway; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Competitive compensation

Pension contributions

Health insurance

Paid holidays

Job summary

Oxford Global Resources in Galway, Ireland, seeks an experienced Design Assurance Engineer to lead quality assurance activities within a remediation initiative for medical devices. You will ensure robust design controls, risk management, and verification strategies across R&D and regulatory interfaces.

The role emphasizes collaboration with cross-functional teams, DHF reviews, and compliance with 13485 and FDA 820, with a focus on maintaining compliant development and post-market activities.

Qualifications

• HETAC Level 8 in a STEM discipline with 2–4 years' relevant experience.
• Experience with risk management, design changes and regulatory standards.
• Practical knowledge of 13485 and FDA Part 820.
• Strong communication and teamwork with initiative.

Responsibilities

• Interface with R&D, Regulatory Affairs, Clinical, Medical Safety, and QA teams; provide technical input.
• Review core DHF records.
• Evaluate verification strategies to confirm TMVs are in place.
• Ensure Design Control requirements are understood and followed.
• Support product development and post-market activities with quality input.
• Identify and resolve complex exceptions to work assignments.
• Contribute to quality improvements in products and processes.

Skills

Risk management

Design change management

Process change management

Regulatory compliance

Communication skills

Teamwork

Initiative

Education

HETAC Level 8 in STEM

Job description

Oxford Global Resources in Galway, Ireland, seeks an experienced Design Assurance Engineer to lead quality assurance activities within a remediation initiative for medical devices. You will ensure robust design controls, risk management, and verification strategies across R&D and regulatory interfaces.

The role emphasizes collaboration with cross-functional teams, DHF reviews, and compliance with 13485 and FDA 820, with a focus on maintaining compliant development and post-market activities.