At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
R&D/Scientific QualityJob Category:
ProfessionalAll Job Posting Locations:
Galway, IrelandJob Description:
We are searching for the best talent for a Senior Design Quality Engineer.PurposeWe are looking for a Senior Design Quality Engineer to join our team.
In this role, we provide design quality and compliance expertise to support the development of new products and improvements to existing products. We work closely with cross‑functional teams to ensure customer needs are met while maintaining compliance with applicable regulations and company requirements.
This role plays a key part in design control, risk management, and quality system activities across the product lifecycle, including development, manufacturing, and post‑market support.
You will be responsible for- Ensuring Design Control and Risk Management activities comply with applicable processes and regulatory requirements
- Acting as a Design Quality team member supporting new product development and lifecycle management activities
- Providing guidance on medical device regulations and design control requirements across global markets
- Supporting product development teams in the effective application of design controls and risk management principles
- Partnering with design teams to define design inputs and outputs, support verification and validation activities, and contribute to process validation, design transfer, and launch planning
- Ensuring critical‑to‑quality requirements are identified and translated into design and process specifications
- Supporting and developing risk management activities, including identification of risks and implementation of control measures
- Managing and delivering quality outputs for R&D projects
- Providing guidance and support to Design Quality Engineers and Quality Engineers
- Coordinating Design Quality resources to support business priorities, where needed
- Engaging with cross‑functional partners to resolve issues and drive alignment
- Applying structured problem‑solving approaches to identify, communicate, and resolve quality issues
- Supporting design reviews and maintaining accurate design control records
- Reviewing and approving R&D and production batch documentation, including sterilization records, to support timely project progression
- Supporting bench testing activities as required
- Monitoring Quality Management System data and identifying trends or issues
- Leading or supporting quality system improvement activities, including CAPA and nonconformance management
- Supporting internal and supplier audits and participating in inspections as needed
- Collaborating with Regulatory Affairs on submissions and deliverables
- Supporting complaint investigations, escalation activities, and post‑launch CAPA where required
- Delivering quality system training and promoting quality awareness across the organization
- Ensuring compliance with all applicable regulations, policies, and procedures
- Degree in an engineering or technical discipline
- Minimum 5 years of experience in the medical device, IVD, or pharmaceutical industry
- Experience working with Quality Management Systems and design control processes
- Strong knowledge of design control, risk management, sterilization, and quality assurance processes
- Working knowledge of 21 CFR 820 and ISO 13485, with familiarity of global regulatory requirements
- Experience preparing for and participating in regulatory inspections (e.g., FDA, Notified Body)
- Ability to manage multiple projects and prioritize effectively in a dynamic environment
- Strong problem‑solving skills and ability to identify and address key quality risks
- Ability to work independently and collaboratively within cross‑functional and global teams
- Clear communication skills, with the ability to present complex information in a structured way
- Ability to build strong working relationships across functions such as Product Development, Regulatory Affairs, Manufacturing, and Marketing
- Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity
We offer a collaborative and inclusive environment where we work together to deliver high‑quality products and continuously improve our processes. This role provides opportunities to contribute to innovative product development, strengthen technical expertise, and grow within the organization.
Our commitment to inclusionWe are an equal opportunity employer and value diversity in our workforce. We welcome applications from people of all backgrounds, experiences, and perspectives.
If reasonable accommodation is needed during the recruitment process or while performing the role, support is available at every stage—please let us know how we can help.
#LI-Onsite
Required Skills:
Preferred Skills:
Agility Jumps, Business Behavior, Coaching, Compliance Management, Continuous Improvement, Database Backup, Data Savvy, Disruptive Innovations, Issue Escalation, Problem Solving, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing
The anticipated base pay range for this position is:
€52 400,00 - €82 915,00Benefits:
In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.
Skills Required
- Degree in an engineering or technical discipline
- Minimum 5 years of experience in the medical device, IVD, or pharmaceutical industry
- Strong knowledge of design control, risk management, sterilization, and quality assurance processes
- Working knowledge of 21 CFR 820 and ISO 13485, with familiarity of global regulatory requirements
- Experience preparing for and participating in regulatory inspections
- Ability to manage multiple projects and prioritize effectively in a dynamic environment
- Strong problem-solving skills and ability to identify and address key quality risks
- Ability to work independently and collaboratively within cross-functional and global teams
- Clear communication skills, with the ability to present complex information in a structured way
- Ability to build strong working relationships across functions such as Product Development, Regulatory Affairs, Manufacturing, and Marketing
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
-
Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
-
Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
-
Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
