Senior PQV Analyst: Combination Product Quality & MDR

8562-Cilag AG Legal Entity; Schaffhausen; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Johnson & Johnson seeks a PQV Quality Analyst to manage high-volume complaint handling and MDR assessments across the EMEA region. The role requires strong QA/QC expertise, regulatory knowledge, and leadership in coordinating cross-functional teams including safety, manufacturing and LOCs.

You will drive process improvements, ensure timely documentation, and support audits and regulatory inquiries while maintaining high standards of quality and compliance.

Qualifikationen

• Bachelor’s or master’s degree in technical, scientific or engineering disciplines.
• 5+ years of related experience in QA/QC within regulated industries.
• Strong knowledge of regulatory requirements (e.g., GMP/GQP) and risk assessment.

Aufgaben

• Lead end-to-end complaint handling and MDR assessment activities.
• Coordinate investigations, root cause analysis and CAPA updates.
• Provide guidance to PQV peers and ensure compliant documentation.
• Collaborate with Global Medical Safety, manufacturing sites and LOC.
• Prepare regulatory submissions and support audits/inspections.
• Monitor KPIs and drive continuous improvement in QC processes.

Kenntnisse

Quality Assurance

Quality Control

Regulatory Compliance

Root Cause Analysis

Process Improvement

Stakeholder Engagement

Project Management

Ausbildung

Bachelor's degree

Master's degree (preferred)

Jobbeschreibung

Johnson & Johnson seeks a PQV Quality Analyst to manage high-volume complaint handling and MDR assessments across the EMEA region. The role requires strong QA/QC expertise, regulatory knowledge, and leadership in coordinating cross-functional teams including safety, manufacturing and LOCs.

You will drive process improvements, ensure timely documentation, and support audits and regulatory inquiries while maintaining high standards of quality and compliance.