Senior Design Quality Engineer

About Johnson & Johnson MedTech

At Johnson & Johnson, health is our utmost priority. As a leader in healthcare innovation, we strive to create a future where complex diseases are effectively prevented, treated, and cured. Our expertise spans Innovative Medicine and MedTech, enabling us to offer smarter, less invasive treatments and personalized healthcare solutions that transform lives worldwide.

We are committed to fostering an inclusive workplace that honors diversity, respects every individual, and values the merit of our employees globally.

Role Overview

We are seeking a Senior Design Quality Engineer to join our Galway team. This key role provides expert guidance on design quality and regulatory compliance to support new product development as well as enhancements to existing products. The successful candidate will collaborate with cross-functional teams to ensure that customer requirements are met, while adhering to regulatory and company standards.

Key Responsibilities

• Ensure adherence to Design Control and Risk Management protocols in compliance with relevant regulations and internal processes.
• Serve as a core member of the Design Quality team, supporting new product initiatives and lifecycle management activities.
• Advise on medical device regulatory standards and design control requirements applicable across international markets.
• Support product development teams in applying design control and risk management methodologies effectively.
• Collaborate with design teams to establish design inputs and outputs, assist verification and validation, and participate in process validation, design transfer, and launch planning.
• Translate critical-to-quality requirements into design and process specifications.
• Lead risk management activities, including identifying risks and implementing control actions.
• Manage and deliver quality outputs for research and development projects.
• Provide mentorship and support to Design Quality Engineers and Quality Engineers.
• Coordinate Design Quality resources to meet business priorities as needed.
• Work closely with cross-functional partners to resolve issues and align strategies.
• Apply structured problem-solving techniques to identify, communicate, and resolve quality concerns.
• Facilitate design reviews and ensure proper maintenance of design control documentation.
• Review and approve R&D and production batch documents, including sterilization records, to support seamless project advancement.
• Support bench testing activities when required.
• Monitor data from the Quality Management System (QMS) to identify trends or quality issues.
• Lead or assist quality system improvement initiatives such as Corrective and Preventive Actions (CAPA) and nonconformance management.
• Support internal and supplier audits and participate in regulatory inspections as necessary.
• Collaborate with Regulatory Affairs in preparing submissions and regulatory deliverables.
• Assist in complaint investigations, escalations, and post-launch CAPA activities.
• Deliver training on quality system practices and foster a culture of quality awareness across the organization.
• Ensure full compliance with all relevant regulations, company policies, and procedures.

Required Qualifications

• Bachelor’s degree in engineering or a related technical discipline.
• At least 5 years of experience within medical devices, in vitro diagnostics (IVD), or pharmaceutical industries.
• Experience with Quality Management Systems and design control processes.
• In-depth knowledge of design control, risk management, sterilization, and quality assurance practices.
• Proficiency in 21 CFR 820 and ISO 13485 standards, with understanding of global regulatory requirements.
• Experience preparing and participating in regulatory inspections, including FDA and Notified Body audits.
• Strong project management skills with the ability to prioritize tasks effectively in a fast-paced environment.
• Excellent problem-solving abilities and risk identification skills.
• Capable of working autonomously and collaboratively within global, cross-functional teams.
• Effective communication skills to present complex information clearly and structured.
• Ability to build strong relationships with stakeholders in Product Development, Regulatory Affairs, Manufacturing, and Marketing.
• Familiarity with AI concepts and frameworks, with an understanding of responsible and ethical AI use and proficient at employing prompting techniques to enhance efficiency.

Compensation & Benefits

The expected salary range for this position is €52,400 to €82,915 annually.

Beyond base compensation, we offer an annual bonus scheme based on employee and company performance, vacation time, parental leave (minimum 12 weeks), bereavement and caregiver leaves, volunteer leave, wellness reimbursements, and programs supporting financial, physical, and mental health. Employees and eligible dependents can also participate in various insurance plans and receive service anniversary and recognition awards.

Our Commitment

We value and encourage diversity and inclusion in our workforce, welcoming candidates from all backgrounds and experiences. Support is available at all stages of recruitment and employment to accommodate reasonable needs.