Senior Design Quality Engineer - MedTech Compliance

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

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson in Galway seeks a Senior Design Quality Engineer to provide design quality and compliance expertise across the product lifecycle, partnering with cross-functional teams to meet customer needs while complying with regulatory requirements.

You will drive design control, risk management, verification and validation activities, and support lifecycle management, with focus on 21 CFR 820, ISO 13485, and regulatory inspections.

Qualifications

• Bachelor's or higher in an engineering discipline or related technical field.
• Experience with medical devices, IVD, or pharmaceuticals is required.
• Knowledge of QMS, design control, and regulatory expectations is essential.

Responsibilities

• Ensure design control and risk management activities meet processes and regulatory requirements.
• Support product development and lifecycle management with design quality principles.
• Provide guidance on medical device regulations across global markets.
• Collaborate with cross-functional teams to translate design inputs into outputs.

Skills

QMS

Design Control

Risk Management

Regulatory Knowledge

Cross-functional Teamwork

Education

Engineering degree

Job description

Johnson & Johnson in Galway seeks a Senior Design Quality Engineer to provide design quality and compliance expertise across the product lifecycle, partnering with cross-functional teams to meet customer needs while complying with regulatory requirements.

You will drive design control, risk management, verification and validation activities, and support lifecycle management, with focus on 21 CFR 820, ISO 13485, and regulatory inspections.