Johnson & Johnson Karrieren
Senior Quality Engineer
Requisition ID: 1805698056W
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.
- 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
Cilag GmbH International (8525)