Transportation Quality Specialist

Johnson & Johnson

. Support EMEA Commercial Quality and Safety Surveillance activities, including post-market surveillance, quality system compliance, and safety reporting .

Posted 11/11/2026full-timeLeeds • United KingdomJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality System Compliance, Post-Market Surveillance, and Safety Reporting within the medical device industry, with a strong focus on regulatory readiness and continuous improvement of quality processes. Proficient in managing quality documentation and collaborating across functions to resolve compliance issues.

Highest-signal resume keywords

Quality System CompliancePost-Market SurveillanceISO 13485Regulatory AffairsQuality Documentation Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsVigilanceTrend AnalysisComplaint HandlingRegulatory ComplianceCQSS Metrics TrackingInvestigations SupportDocumentation ProceduresAudits ParticipationSafety Reporting

Soft Skills

Attention to DetailEffective CommunicationCollaborationAbility to Manage Multiple Priorities

Tools & Technologies

Quality DatabasesReporting Tools

Certifications & Qualifications

ASQ CertificationISO Lead Auditor Certification

Industry Keywords

EMEA RegionMedical Device IndustryEU MDRIVDRRegulated Industry

About the role

Key responsibilities & impact

Support EMEA Commercial Quality and Safety Surveillance activities, including post-market surveillance, quality system compliance, and safety reporting
Execute and maintain quality system documentation, including procedures, work instructions, and CQSS records
Participate in complaint handling, vigilance, and trend analysis to identify and escalate quality and safety issues
Support internal and external audits, inspections, and regulatory inquiries by preparing documentation and responding to information requests
Collaborate with Regulatory Affairs, Medical Safety, Operations, and other cross-functional partners on investigations and resolution of quality and compliance issues
Contribute to continuous improvement of CQSS processes, tools, and reporting
Maintain accurate tracking and reporting of CQSS metrics for management review and regulatory compliance
Support product quality, regulatory compliance, patient safety, and regulatory readiness across the EMEA region

Requirements

What you’ll need

Bachelor’s degree required in a scientific, engineering, healthcare, or related discipline
Typically 2–4 years of relevant work experience in Quality, Compliance, Regulatory Affairs, or a related function within a regulated industry
Working knowledge of quality systems and compliance requirements, including ISO 13485, post-market surveillance, and vigilance
Experience supporting investigations, documentation, and quality records in accordance with established procedures
Strong attention to detail and ability to manage multiple priorities in a regulated environment
Proficiency in English required; additional EMEA language skills are a plus
Limited regional travel may be required, generally up to 10%
Experience supporting EMEA-based quality, vigilance, or regulatory activities within the medical device industry preferred
Familiarity with EU MDR/IVDR post-market surveillance and safety reporting requirements preferred
Experience participating in audits or health authority inspections preferred
Proficiency with quality systems, databases, and reporting tools preferred
Effective written and verbal communication skills, with ability to collaborate across functions and regions
Quality or Regulatory certifications, such as ASQ or ISO Lead Auditor, preferred but not required

Benefits

Comp & perks

Inclusive work environment
Employee wellness, career, and life support resources
Benefit plans (subject to the planned DePuy Synthes separation and applicable consultation processes)