Senior Design Quality Engineer

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

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson MedTech in Galway, Ireland is seeking a Senior Design Quality Engineer to lead design control, risk management, and quality system activities across the product lifecycle.

You will provide design quality and compliance expertise for new product development and existing product improvements, collaborating with cross-functional teams to meet customer needs while adhering to 21 CFR 820, ISO 13485 and global regulatory requirements.

Qualifications

• Degree in an engineering or technical discipline.
• Experience with Quality Management Systems and design control processes.
• Familiarity with 21 CFR 820 and ISO 13485; regulatory inspections experience preferred.

Responsibilities

• Ensure Design Control and Risk Management activities comply with processes and regulatory requirements.
• Support product development, lifecycle management and design transfer activities.
• Provide guidance on medical device regulations and design control across global markets.
• Collaborate with cross-functional teams to define design inputs/outputs and support verification & validation.

Skills

Quality mindset

Cross-functional collaboration

Regulatory knowledge

Problem solving

Effective communication

Education

Engineering degree

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function

Quality

Job Sub Function

R&D/Scientific Quality

Job Category

Professional

All Job Posting Locations

Galway, Ireland

Job Description

We are searching for the best talent for a Senior Design Quality Engineer.

Purpose

We 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.

• 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

Qualifications / Requirements

• 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

What we offer

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 inclusion

We 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.

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 - €82 915,00

Benefits

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.