Senior Quality & MDR Analyst - Combination Products

Johnson & Johnson Innovation; Antwerpen; Sur place; EUR 63 000 - 101 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson Innovation seeks a PQV Combination Product Analyst IV to lead high-volume end-to-end complaint handling and MDR assessments across global sites. You will supervise investigations, drive risk-based decisions, and mentor PQV staff while coordinating with Medical Safety, QA, and manufacturing partners to ensure compliant, timely documentation.

Location includes multiple Beerse/Antwerp sites in Belgium with international collaboration and travel as needed.

Responsabilités

• Perform high-volume end-to-end complaint handling activities, including intake, triage, event review, MDR reportability, and regulatory documentation.
• Evaluate complaints to determine investigation level and assign to site for investigation.
• Governance for daily throughput of complaints and MDR decisions to meet KPI.
• Perform MDR evaluations and document justifications for regulatory decisions.
• Monitor complaints for new malfunction events and update MDL.
• Provide guidance to PQV peers and interact with regulatory bodies as SME.
• Coordinate and lead root cause identification and CAPA within QMS.
• Lead process mapping and change for SOPs, WI’s and job aids.
• Train complaint management system end users and support internal audits.
• Interact with IT partners and external vendors as required.

Description du poste

Johnson & Johnson Innovation seeks a PQV Combination Product Analyst IV to lead high-volume end-to-end complaint handling and MDR assessments across global sites. You will supervise investigations, drive risk-based decisions, and mentor PQV staff while coordinating with Medical Safety, QA, and manufacturing partners to ensure compliant, timely documentation.

Location includes multiple Beerse/Antwerp sites in Belgium with international collaboration and travel as needed.