Lead Design Quality Engineer (MedTech)

Location: Galway, Ireland; hybrid working arrangements may be available. International travel of approximately 5–10% may be required.

Salary: €63,300–€101,315 annual base pay.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions designed to improve patient outcomes.

What you will do

• Lead Design Control and Risk Management activities for new product development and product lifecycle management.
• Partner with R&D, Regulatory Affairs, Manufacturing, suppliers, and other cross-functional stakeholders.
• Support product launches, design transfers, verification and validation, process validation, and launch planning.
• Define critical-to-quality requirements, risk controls, design inputs, design outputs, and process specifications.
• Lead or facilitate CAPA, non-conformance, complaint investigation, audit, inspection, and regulatory activities.
• Provide technical leadership, mentor Design Quality Engineers, maintain design control records, and contribute to quality and regulatory guidelines.

Requirements

• Degree in Engineering, Science, or another relevant technical field.
• At least 6 years of experience in medical devices, IVD, pharmaceuticals, or a related regulated industry.
• At least 3 years of direct responsibility for Quality Management System processes or sub-processes.
• Experience with new product development, product lifecycle management, FDA and Notified Body inspections.
• Strong knowledge of Design Control, Risk Management, Quality Assurance, CAPA, non-conformance management, 21 CFR Part 820, and ISO 13485.
• Ability to lead multiple projects, solve complex problems, and collaborate effectively with global multifunctional teams.

Nice to have

• Knowledge of sterilization and additional international medical device regulations.
• Experience supporting regulatory submissions and post-launch activities.

Culture & Benefits

• Collaborative and inclusive environment focused on innovation, learning, and professional development.
• Opportunity to work with global teams on medical technologies that support patient outcomes.
• Annual bonus with a target based on pay grade and location.
• Vacation, parental, bereavement, caregiver, and volunteer leave.
• Well-being reimbursement, financial, physical and mental health programs, recognition awards, and eligible insurance plans.