Senior Quality-Systems Engineer

Johnson Johnson; Ireland; On-site; EUR 83,000 - 138,000; Full time

Job summary

Johnson & Johnson MedTech seeks a Senior/Staff EUDAMED Quality Engineer to lead EU MDR and EUDAMED compliance across the organization. You will own QMS documentation, risk management, and data governance while coordinating cross-functional teams in Regulatory, Quality, Supply Chain, Vigilance, and Clinical.

You will drive process harmonization, lifecycle management, and deployment readiness for EUDAMED modules, ensuring scalable, compliant operations across sectors.

Qualifications

• 7+ years in Medical Devices or Life Sciences within Quality Systems, Regulatory Affairs, Data Management, or Process Excellence.
• Direct experience with EU MDR and EUDAMED module deployments.
• Hands-on experience with Data Governance, Master Data Management (MDM), and data quality tools.

Responsibilities

• Maintain EUDAMED QMS documentation, standards, work instructions, quality plans, and training curricula to ensure continuous alignment with EU MDR.
• Lead compliance reviews, gap assessments, internal/external audits, CAPA, change control, risk management, and organizational changes.
• Evaluate EU MDR/EUDAMED updates to assess cross-module risks and implement quality system adjustments.
• Establish end-to-end process workflows, role descriptions, and data governance frameworks for data accuracy and lifecycle compliance.
• Lead process improvement initiatives to standardize EUDAMED operations across sectors and franchises.
• Act as lead business analyst to gather cross-functional requirements, translate regulatory rules into operational controls, and design scalable operating models.
• Evaluate new EUDAMED functionality/releases, coordinate user testing, and handle system outage responses.
• Oversee user access governance, training delivery, and readiness for upcoming module deployments.
• Manage internal/external EUDAMED communication and provide guidance to operational teams.

Skills

Cross-functional leadership

Quality Systems

Regulatory Affairs

Data governance

Process design

Risk management

CAPA

Change control

Data mapping

Stakeholder management

MDM

Data quality tools

EU MDR knowledge

EUDAMED modules

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

QMS software

Data governance tools

Job description

Imagine your next project driving EU MDR compliance and data governance across Johnson & Johnson MedTech as a key quality systems leader.

The Senior/Staff EUDAMED Quality Engineer leads Johnson & Johnson MedTech’s compliance with EU MDR and EUDAMED requirements. This role drives quality systems management, data governance, business process design, and operational sustainment across all MedTech sectors. The position requires strong cross-functional leadership (Quality, Regulatory, Supply Chain, Vigilance, Clinical) to establish scalable, compliant, and sustainable EUDAMED processes.

roles and responsibilities.

• Procedure & Governance Ownership: Maintain EUDAMED QMS documentation, standards, work instructions, quality plans, and training curricula to ensure continuous alignment with EU MDR.
• Audit & Lifecycle Support: Lead compliance reviews, gap assessments, internal/external audits, CAPA, change control, risk management, and organizational changes (acquisitions, divestitures, legal transfers).
• Regulatory Monitoring: Evaluate EU MDR/EUDAMED functional updates to assess cross-module business risks and implement necessary quality system adjustments.
• Data & Process Mapping: Establish end-to-end process workflows, role descriptions, and data governance frameworks to ensure data accuracy, stewardship, and lifecycle compliance.
• Process Harmonization: Lead process improvement initiatives to standardize and simplify EUDAMED operations across all sectors and franchises.
• Business Analysis: Act as lead business analyst to gather cross-functional requirements, translate regulatory rules into operational controls, and design scalable operating models.
• Release & System Management: Evaluate new EUDAMED functionality/releases, coordinate user testing, manage European Commission Helpdesk escalations, and handle system outage responses.
• Access & Readiness: Oversee user access governance, training delivery, and cross-functional readiness for upcoming module deployments.
• Stakeholder Support: Manage internal/external EUDAMED communication channels and provide expert guidance to operational teams.

how to succeed.

• Education: Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Data Management, or a related field.
• Experience: 7+ years in Medical Devices or Life Sciences within Quality Systems, Regulatory Affairs, Data Management, or Process Excellence.
• Technical Skills: Deep knowledge of QMS frameworks, GxP environments, business process mapping, and requirements gathering.
• Soft Skills: Proven ability to influence without authority, navigate regulatory ambiguity, and manage senior stakeholders across a matrixed organization.
• Direct experience with EU MDR and EUDAMED module deployments.
• Hands-on experience with Data Governance, Master Data Management (MDM), and data quality tools.

This role offers a very competitive hourly rate. This contract will run for Not specified

you are welcome here.

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson MedTech

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopaedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalised.

Diversity, Equity & Inclusion.

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.