Key Responsibilities 

• Provide  oversight for global UDI technology platforms, data flows, and supporting systems to ensure regulatory compliance and data integrity. 

• Support development, implementation, and maintenance of UDI‑related quality processes, procedures, and controls across the product lifecycle. 

• Partner with IT and business stakeholders to ensure UDI systems are validated, maintained, and compliant with applicable quality system regulations. 

• Review and approve UDI‑related documentation, including system validation deliverables, change controls, risk assessments, and procedural updates. 

• Monitor and assess UDI data accuracy, completeness, and timeliness across internal systems and external regulatory databases. 

• Support internal and external audits, inspections, and health authority interactions related to UDI and supporting technologies. 

• Identify quality risks, trends, and improvement opportunities related to UDI processes and digital solutions; drive corrective and preventive actions. 

• Provide quality guidance and training to cross‑functional partners on UDI requirements, quality standards, and system controls. 

Qualifications 

Education 

• Required: Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related discipline. 

• Preferred: Advanced degree in Quality, Regulatory, or a technical field. 

Experience and Skills 

Required: 

• Typically 4–8 years of experience in Quality Assurance, Quality Systems, or Regulatory‑adjacent roles within medical devices, pharmaceuticals, or regulated industries. 

• Experience supporting validated systems and technology platforms in a regulated environment. 

• Working knowledge of global UDI regulations (e.g., FDA, EU MDR) and quality system requirements. 

• Experience with change control, risk management, and documentation review within a quality framework. 

• Demonstrated ability to analyze quality data, identify trends, and drive continuous improvement. 

Preferred: 

• Experience with UDI databases, labeling systems, or enterprise data management platforms. 

• Familiarity with computer system validation (CSV) and digital quality controls. 

• Experience supporting regulatory inspections or audits related to data integrity or digital systems. 

• Knowledge of Lean, Six Sigma, or continuous improvement methodologies. 

• Experience working in a global or matrixed organization. 

• Strong collaboration skills with the ability to work effectively across global, cross‑functional teams. 

Other: 

• Language: English proficiency required. 

• Travel: Up to ~10–15%, domestic and occasional international. 

• Certifications: ASQ certifications (e.g., CQA, CQE) or similar quality certifications preferred. 

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.