Senior PQV Analyst — MDR & Complaint Management

Johnson & Johnson Innovative Medicine; Ringaskiddy; Sur place; EUR 63 000 - 101 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson is seeking a PQV Analyst IV to manage high-volume E2E product quality complaints and MDR assessments. The role requires collaboration across multiple functions and regions to drive process improvements and ensure regulatory compliance.

The position emphasizes leadership in change management, risk assessment, and data-driven decision making, with a focus on delivering accurate investigations and timely regulatory reporting.

Qualifications

• 5+ years of related experience in Quality Assurance/Quality Control in regulated industry.
• Knowledge of medical safety environment and regulatory requirements.
• Strong organization skills with ability to prioritize and manage workload.

Responsabilités

• Perform end-to-end complaint handling activities and MDR assessments.
• Lead change management and drive process improvements in PQV functions.
• Collaborate with Global Medical Safety, manufacturing sites and LOC/BQ for effective complaint handling.

Connaissances

Quality

Quality Assurance

Regulatory awareness

Project leadership

Formation

Bachelor’s or Master’s degree in technical/scientific/engineering disciplines

Outils

GMP

QMS

SOPs

Description du poste

Johnson & Johnson is seeking a PQV Analyst IV to manage high-volume E2E product quality complaints and MDR assessments. The role requires collaboration across multiple functions and regions to drive process improvements and ensure regulatory compliance.

The position emphasizes leadership in change management, risk assessment, and data-driven decision making, with a focus on delivering accurate investigations and timely regulatory reporting.