PQV Combination Product Analyst IV
Johnson & Johnson · Cork, Ireland +2 more
Medical DeviceFull-timeCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Johnson & Johnson seeks a PQV Combination Product Analyst IV to manage high-volume product quality complaints and adverse events, including Medical Device Reporting assessments. The role involves end-to-end complaint handling, regulatory compliance, cross-functional collaboration, and process improvement leadership across multiple manufacturing sites and regions.
What they're looking for
- Medical Device Reporting (MDR) assessment and regulatory reporting experience
- Knowledge of product quality vigilance, complaint handling, and adverse event processes
- Ability to evaluate technical information and perform risk criticality assessment
- Experience with quality management systems, CAPA, and regulatory compliance procedures
- Strong communication and stakeholder engagement skills across functional areas
- Project leadership and process improvement experience using quality tools
What you'll be doing
- Perform end-to-end complaint handling including intake, triage, MDR reportability determination, and closure
- Evaluate complaints against quality thresholds and assign investigations to applicable sites
- Monitor daily complaint throughput and MDR decisions to ensure KPI targets are met
- Serve as PQV subject matter expert for post-market regulatory and MDR questions
- Lead process mapping, SOP development, and process improvement initiatives using data-driven approaches
Privacy & handoff
This role links to Johnson & Johnson's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.