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Johnson & Johnson Karrieren

Senior Quality Engineer

Schaffhausen, Schweiz
Quality (Eng)


Arbeitsplatzbeschreibung

Requisition ID: 1805698056W

 

‘Caring for the world, one person at a time ‘… inspires and unite the people of Johnson & Johnson, we embrace research and science- bringing innovative ideas, products and services to advance the health and well-being of people
Janssen Pharmaceutical is part of Johnson & Johnson and responsible for bringing innovative medicines towards patients throughout the world.
 
 
Senior Quality Engineer
 
  • Lead, conduct and support through close cooperation with the manufacturing sits the complaint investigations for Janssen Combo Products PQCs being accountable for accuracy and quality of investigation.
  • Use technical and product knowledge for accurate feedback for current product enhancements and future product development, and for escalation/awareness of issues.
  • Evaluate information from a technical perspective to insure appropriate analysis, investigation and failure modes have been analyzed and documented during the complaint investigation.
  • Provide guidance and expertise to internal and external business partners for the interpretation, implementation, and execution of QSR requirements related to product complaint investigation.
  • Provide coaching, training, and development of personnel, internally and externally to CCV, in documenting effective investigations.
  • Coordinate and support Failure Investigations.
  • Lead projects for Complaint Vigilance; collaborate across departments and sites:
    • Lead complex investigations within Complaint Vigilance
    • Lead new business projects (external manufacturers, distributed products) to ensure compliant and effective data / knowledge transfer.
  • Support Regulatory and Field Actions Committees, Health Authority Inspections
  • Be liaison with R&D and New Product Introduction teams to ensure new product readiness for complaint vigilance quality process support and other functions.
  • Participates directly or indirectly on Complaint Vigilance Review Board and project teams to develop, consolidate and/or improve complaint vigilance and related/interfacing processes and metrics.
  • Present to senior management complaint vigilance outcomes and interact with Device Experts/Product Quality Owners/Product Quality Integrators to recommend improvements and improve overall risk of the product.

Qualifikationen
  • 5+ years of Medical Device or Pharmaceutical industry experience required;
  • 2-5+ years of Complaint Management, Post Market Vigilance, Risk Management, or Compliance experience required. Supervisory experience desirable.
  • Green Belt (Six Sigma) desirable or other formal investigation training required; CQE (ASQ) certification preferred or equivalent.
  • Ability to work individually as well as on a team.
  • Ability to communicate effectively verbally and in writing (technical and persuasive).
  • Ability to present to multiple levels and departments within the organization
  • English fluently
  • German advanced

 


  • Primärer Standort
    Schweiz-Schaffhausen-Schaffhausen-
    Organisation
    Cilag GmbH International (8525)
    Funktion
    Quality (Eng)
    Requisition ID
    1805698056W