Senior Design Quality Engineer — Hybrid, Strategic QA

jj; Galway; Hybrid; EUR 52,000 - 83,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson in Galway, Ireland seeks a Senior Design Quality Engineer to lead design quality and risk management across the product lifecycle. You will partner with cross-functional teams to ensure customer needs are met while maintaining regulatory compliance.

In this role you will influence design control, risk management, sterilization, and quality assurance activities, supporting development, manufacturing, and post‑market support with a strong emphasis on global regulatory

Qualifications

• Degree in an engineering or technical discipline.
• Minimum 5 years of experience in medical device, IVD, or pharmaceutical industry.
• Experience with Quality Management Systems and design control processes.
• Strong knowledge of design control, risk management, sterilization, and QA processes.
• Working knowledge of 21 CFR 820 and ISO 13485; familiarity with global regulatory requirements.
• Experience preparing for regulatory inspections (FDA, Notified Bodies).

Responsibilities

• Ensure Design Control and Risk Management activities meet processes and regulatory requirements.
• Support new product development and lifecycle management as part of the Design Quality team.
• Provide guidance on medical device regulations and design control for global markets.
• Assist product teams with design inputs/outputs, verification, validation, and process validation.
• Identify critical-to-quality requirements and translate into design/process specs.
• Lead or support risk management activities and CAPA/nonconformance actions.
• Coordinate with cross-functional partners to resolve issues and align on quality objectives.
• Review R&D and production batch documentation to support timely progression.
• Deliver quality outputs for R&D projects and train Design Quality Engineers.

Skills

Design controls

Risk management

Quality management systems

21 CFR 820

ISO 13485

FDA inspections

Regulatory inspections

Cross-functional collaboration

Problem solving

Quality system improvements

Quality assurance processes

Education

Engineering or technical degree

Job description

Johnson & Johnson in Galway, Ireland seeks a Senior Design Quality Engineer to lead design quality and risk management across the product lifecycle. You will partner with cross-functional teams to ensure customer needs are met while maintaining regulatory compliance.

In this role you will influence design control, risk management, sterilization, and quality assurance activities, supporting development, manufacturing, and post‑market support with a strong emphasis on global regulatory