Senior Design Quality Engineer

About Johnson & Johnson MedTech

Johnson & Johnson is dedicated to advancing health through innovative medical technologies. Our expertise spans innovative medicines and MedTech, enabling the creation of smarter, less invasive, and personalized healthcare solutions worldwide.

We prioritize inclusion, respect diversity, and uphold dignity for all employees, fostering an inclusive environment across the globe.

Role Overview

We are seeking a Senior Design Quality Engineer to join our Galway-based team. This role focuses on providing expert support in design quality and regulatory compliance during new product development and continuous improvement of existing medical devices.

Key Responsibilities

• Ensure adherence to Design Control and Risk Management procedures aligned with regulatory requirements.
• Act as a critical member of the Design Quality team supporting product development and lifecycle management.
• Provide expertise on global medical device regulations and design control standards.
• Guide product teams on applying design controls and risk management effectively.
• Collaborate with design teams to define inputs, outputs, and support verification, validation, and process validation activities.
• Identify critical quality attributes and integrate them into design and process specifications.
• Manage and advance risk management activities including risk identification and mitigation.
• Lead quality deliverables for R&D projects and mentor fellow Design Quality Engineers and Quality Engineers.
• Coordinate cross-functional design quality resources to meet business objectives.
• Engage stakeholders to resolve issues and align quality priorities.
• Employ structured problem-solving to address and communicate quality challenges.
• Support design reviews and maintain comprehensive design control documentation.
• Review and approve documentation related to R&D and production including sterilization records for smooth project progress.
• Assist with bench testing and monitor Quality Management System data to detect trends or issues.
• Drive quality system enhancements including CAPA and nonconformance management.
• Participate in internal and supplier audits and regulatory inspections as needed.
• Collaborate with Regulatory Affairs on submissions and compliance deliverables.
• Support complaint investigations, escalations, and post-launch corrective actions.
• Deliver training to promote quality consciousness throughout the organization.
• Ensure organizational compliance with all applicable regulations, policies, and procedures.

Qualifications & Experience

• Degree in engineering or a relevant technical field.
• A minimum of five years’ experience in medical device, in vitro diagnostics, or pharmaceutical industries.
• Proven knowledge of Quality Management Systems and design control workflows.
• Strong familiarity with design control, risk management, sterilization, and overall quality assurance.
• Understanding of 21 CFR 820 and ISO 13485 standards, including global regulatory frameworks.
• Experience in preparing for and participating in regulatory inspections such as FDA and Notified Body audits.
• Ability to manage multiple projects and prioritize work in a fast-paced environment.
• Excellent problem-solving skills with the ability to identify and mitigate key quality risks.
• Capable of working independently as well as collaboratively in global, cross-functional teams.
• Strong communication skills, able to structure complex information clearly and concisely.
• Capacity to foster strong working relationships across departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.
• Knowledge of artificial intelligence concepts including ethical AI practices and applying effective AI prompting techniques to improve productivity.

Compensation & Benefits

The salary range for this position is €52,400 to €82,915 annually. Additional benefits include an annual performance bonus or sales commissions based on individual and company results, paid vacation, parental leave for at least 12 weeks, bereavement and caregiver leave, volunteer leave, well-being reimbursements, health and financial wellness programs, recognition awards, and eligibility for several insurance plans for employees and their dependents, subject to local terms.

Inclusion Statement

We embrace equal opportunity employment and encourage applications from diverse backgrounds, experiences, and perspectives. Reasonable accommodations are available throughout the recruitment process and work life.