Johnson & Johnson Careers

【Janssen】Fuji Quality Engineer

Fuji, Japan
Quality (Eng)


Job Description

Requisition ID: 1805698059W

  • Conduct and support in close cooperation with the manufacturing sites the investigation of Janssen Product Quality Complaints for Combo Products being responsible for ensuring a complete holistic investigation for PQCs is documented in the PQC database.
  • Suggest improvements to existing methods and processes for conducting PQC investigations.
  • Evaluate information from a technical perspective to ensure appropriate analysis, investigation and failure modes have been analyzed and documented prior to complaint closure.
  • Provide guidance to investigational groups in conducting holistic investigations and appropriate root cause investigations.
  • Ensure updates to Complaint Management system are executed (Device History Record review and scanning, data collection/correction/upload, etc.)
  • Support and coordinate Failure Investigations and assist in the processes for submission of Medical Device Reports based on expected reporting requirements.
  • Management of appropriate Corrective/Preventive actions related to Complaint Investigations
  • Provide product or regional customer insights to reporting/surveillance team that will enable marketing/sales/research and development and other business partners to improve design inputs.
  • Ensure on time escalation as per Escalation Standard/SOP.
  • Support projects for Complaint Vigilance; collaborate across departments and sites.
  • Supports the investigational groups for holistic complaint investigation and analysis by providing adequate training and tools
  • Supports Regulatory and Field Actions Committees, Health Authority Inspections
 

PRINCIPAL RESPONSIBILITIES:

COMPLAINT MANAGEMENT INVESTIGATIONS:
  • Conduct and support holistic complaint investigation support for Janssen Combo Products PQCs.
  • Responsible for utilizing effective and efficient Quality Engineering / Process Excellence techniques.
  • Evaluate information from a technical perspective to ensure appropriate analysis, investigation and failure modes have been analyzed and documented prior to complaint closure.
  • Execute transactional tasks to support the complaint management process (DHR review and scanning, data collection/correction/upload, etc.)
  • Coordinate and support Failure Investigations and assist in the processes for submission of Medical Device Reports.
  • Uses statistical/data-driven processes and documentation to support investigations.
  • Partner with customers (Manufacturing Sites, PDMS, Contact Centers (LOC), Global Medical Safety, Marketing, PQM, Sales Administration, Brand Protection, ESIQ, etc.) to gain knowledge of products and processes.
  • Identify gaps, redundancies and inaccuracies to improve the complaint investigation process.
  • Review and monitor complaint investigation practices across different departments to ensure standard process is followed, data consistency and high data quality for correct decision making.
  • Support internal and external audits and inspections.
  • Act as Single Point of Contact for Schaffhausen (Switzerland) Manufacturing Site for CCV.

% OF TIME

 
80

BUSINESS RELATIONS:

  • Actively manage customer relationships (with JJQS, LOCs, Manufacturing Sites, PDMS, GMS, ESIQ, Product Quality Management, IT, Business Partners, etc.)
  • Drive technical and process improvement and influence change.
  • Solicit customer feedback.
10
DOCUMENTATION:
  • Create and maintain WI´s and SOP´s relative root cause investigation for complaint management processes.
  • Develop and deliver training for colleagues, investigational sites and other partners on complaint investigation process, and product specific information.
  • Supports the technical writing and provides analytical support in correct investigation outcome interpretation to answer Health Authority Requests related to Complaint Handling.
10


Qualifications
  • 3+ years of Medical Device or Pharmaceutical industry experience required;
  • 1-3+ 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; Black Belt (Six Sigma) or CQE (ASQ) certification preferred.
  • Ability to work individually as well as on a team.
  • Ability to work an extended period of time on a computer.
  • Ability to communicate effectively verbally and in writing (technical and persuasive).
Ability to present to multiple levels and departments within the organization.

Primary Location
Japan-Shizuoka-Ken-Fuji-
Organization
Janssen Pharmaceutical K.K. (7195)
Job Function
Quality (Eng)
Requisition ID
1805698059W