Senior Design Quality Engineer (Medical Devices)

Johnson & Johnson MedTech; Galway; On-site; EUR 52,000 - 83,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being programs

Job summary

Johnson & Johnson MedTech is seeking a Senior Design Quality Engineer in Galway to provide design quality and regulatory support across the product lifecycle. You will partner with cross‑functional teams to ensure design controls, risk management, and quality system compliance for new and existing products.

The role requires strong knowledge of design control, sterilization, and ISO 13485, with experience in regulatory inspections and global markets.

Qualifications

• Degree in engineering or technical discipline.
• Minimum 5 years in medical device, IVD, or pharma.
• Knowledge of design control and risk management processes.
• Familiarity with 21 CFR 820 and ISO 13485 and regulatory inspections.

Responsibilities

• Ensure design control and risk management comply with processes and regs.
• Support product development with design quality expertise across lifecycle.
• Guide on medical device regulations across global markets.
• Collaborate with cross‑functional teams to implement design inputs/outputs and VER/VL.
• Lead or support CAPA and nonconformance investigations and quality system improvements.

Skills

Design Quality

Risk Management

Regulatory Knowledge

Quality Systems

Cross-functional Collaboration

Education

Engineering degree

Tools

QMS (ISO 13485)

Job description

Johnson & Johnson MedTech is seeking a Senior Design Quality Engineer in Galway to provide design quality and regulatory support across the product lifecycle. You will partner with cross‑functional teams to ensure design controls, risk management, and quality system compliance for new and existing products.

The role requires strong knowledge of design control, sterilization, and ISO 13485, with experience in regulatory inspections and global markets.