Senior Design Quality Engineer – Medical Device R&D

Antler; Galway; On-site; EUR 52,000 - 83,000; Full time

Benefits offered by this job

Annual bonus

Vacation days and leave

Well-being programs

Job summary

Johnson & Johnson in Galway seeks a Senior Design Quality Engineer to provide design quality and regulatory guidance across the product lifecycle, from development through post‑market support.

You will work with cross‑functional teams to ensure compliance with applicable regulations and company requirements, lead design control activities, and drive risk management and problem‑solving efforts to deliver safe, high‑quality medical devices.

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.
• Familiarity with 21 CFR 820 and ISO 13485 and global regulatory requirements.
• Experience preparing for regulatory inspections (FDA, Notified Body).

Responsibilities

• Ensure Design Control and Risk Management activities comply with processes and regulatory requirements.
• Support new product development and lifecycle management as a Design Quality team member.
• Provide guidance on medical device regulations and design control across global markets.
• Assist cross‑functional teams in design inputs/outputs, verification/validation, and process validation.
• Lead/participate in quality system improvement activities including CAPA and nonconformance management.
• Collaborate with Regulatory Affairs on submissions and deliverables.
• Support audits and inspections as needed.
• Review and approve R&D and production batch documentation.

Skills

Design control

Risk management

Quality assurance

Regulatory inspections

Cross-functional collaboration

Problem solving

Communication

Project management

Education

Degree in engineering or technical discipline

Tools

QMS

FDA/Notified Body regulatory knowledge

Job description

Johnson & Johnson in Galway seeks a Senior Design Quality Engineer to provide design quality and regulatory guidance across the product lifecycle, from development through post‑market support.

You will work with cross‑functional teams to ensure compliance with applicable regulations and company requirements, lead design control activities, and drive risk management and problem‑solving efforts to deliver safe, high‑quality medical devices.