Senior Product Quality Vigilance Engineer

Biopharma Careers; Beerse; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson Beerse is seeking a Senior Quality Engineer within Supply Chain Engineering to lead PQC investigations for Innovative Medicine products and collaborate across sites to ensure readiness and compliance.

The role emphasizes data-driven decision making, cross-functional partnership with R&D, and leadership in quality vigilance projects, while ensuring adherence to QSR requirements and regulatory standards.

Qualifications

• 5+ years of experience including Quality Assurance and/or Quality Control in Pharmaceutical and/or Medical Device industries.
• Knowledge of medical safety environment and regulation.
• 2.5+ years of experience in Complaint Management, Post‑Market Vigilance, Risk Management or Compliance preferred.
• Supervisory experience desirable.
• Global mindset and demonstrated ability for change initiatives, project management, and develop strong working relationships; knowledge of regulatory requirements.
• BA/BS in technical, scientific or engineering disciplines required; MA/MS/MBA desirable.

Responsabilités

• Lead, conduct, and support investigation of Innovative Medicine Product Quality Complaints (PQCs) for commercial and clinical products with site collaboration.
• Coordinate information from a technical perspective to ensure analyses and failure modes are documented before closure.
• Lead Product Quality Vigilance projects and new business initiatives ensuring transfer of knowledge.
• Collaborate across departments/sites with R&D and NPI teams for product readiness and PQV support.
• Act as Site PQV consultant for investigations and surveillance activities.
• Support qualification and audit processes and assist in submission of Medical Device Reports.
• Serve as Single Point of Contact (SPOC) for PQV at Manufacturing Sites; back up other SPOCs as needed.
• Drive continuous improvement, statistical/data-driven decision making and risk management processes.

Connaissances

Quality Assurance

Quality Control

Regulatory knowledge

Project management

Strong communication

Six Sigma

CQE (ASQ)

Global mindset

Change management

Formation

BA/BS in technical, scientific or engineering disciplines

MA/MS/MBA in technical, scientific or engineering disciplines desirable

Description du poste

Johnson & Johnson Beerse is seeking a Senior Quality Engineer within Supply Chain Engineering to lead PQC investigations for Innovative Medicine products and collaborate across sites to ensure readiness and compliance.

The role emphasizes data-driven decision making, cross-functional partnership with R&D, and leadership in quality vigilance projects, while ensuring adherence to QSR requirements and regulatory standards.