Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
SUMMARY
Miyazaki and Tokyo Maihama Technical Service Center (TSC):
Ensure processes and procedures for Technical Service Operations (LBAX/ LHR) in Japan are in compliance to regulatory requirements and Corporate Quality Manual and GS requirements.
Actively participate in the design, implementation and/or maintenance of the quality processes in the field service operations and service center operations in Japan.
Ensure quality assurance compliance in the FA, customer care, field and service center operation processes.
Maintain a strong relationship with the local Global Services team (field operations and service center operations), and relevant Stakeholders (CQA, SQA etc).
Miyazaki Plant QM:
Support training, internal and external audit and quality management review activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Support Miyazaki and Tokyo Maihama Technical Service Center (TSC):
Quality support to Field Service operation activities in Japan.
Quality support to Service Centre operation in Japan.
Global Services Quality Systems Local Process Ownership for Japan: documentation, procedures, training, internal and external audit, CAPA and non-conformities, post marketing surveillance activities (product complaints, medical device vigilance, and Field Actions), supplier qualification, validation process (IQ, OQ, PQ protocols), change control process, risk assessment and support and ensure compliance of field and service center operations processes of Device Release, Labelling, Storage areas, Calibration, Decontamination, Equipment Validations, Repair, PM and/or Spare parts management such as the following, but not limited;
Perform E hold release of product for Technical Service
Oversight of TS Quality KPIs; monitoring for recurring trending and implement continuous improvements and actions.
Oversight of TS CMX (calibration management system) to ensure all calibration requirements are met and adherence to TS calibration metrics.
Oversight of TS BAXU and training matrix to ensure all training requirements are met and adherence to TS training metrics.
Support and/or lead deviation programs associated with Quality issues in Technical Services, provide guidance to ensure investigations and corrective actions are completed on time to meet GQP requirements and utilising quality risk principles
Oversight of TS Change Controls and Validations; ensure changes to systems and processes are documented and reviewed appropriately to meet GQP requirements.
Maintain local TS documentation to ensure current and meets GQP requirements.
Quality point of contact for local and external TS audits. Responsible for preparing and submitting TS audit responses working with Country QMR/CQA.
Support and/or lead local TS QA projects/initiatives as required.
Support TS Complaint/Field Action activities to ensure completion of actions and on time metrics. Track and influence DEA KPI metrics. Tracking return of TS products when required / return of TS products to customer when required (day to day and FA).
Back up for Product Complaint/Field Action tasks as required
Quality KPIs- trending and actions (use of TS systems)
Local QMR for Technical Service, Japan.
Support and /or lead local / regional Service QA and Operational projects / initiatives as required.
Support Miyazaki Plant QM;
Training, Coordinate of internal & regulatory audit, handling of global observation certification, preparation of material and minutes for Management Review.
Education
The function requires a Bachelor degree in electrical/electronic engineering or equivalent degree in the technical / technology field
Experience
Number of years of experience:
Minimum 3-5 years experience in quality management in a medical device or technical service organization – quality processes related to service activity OR experience in technical service/ manufacturing environment
Field of expertise:
Medical Device or Electro-mechanical products
Functional/specific competencies
Quality System and Quality Assurance knowledge in operations - knowledge of Pharmaceuticals and Medical Devices Law, GMP, QMS.
Ability to manage with different tasks in an international environment
