Senior Quality Specialist, Technical Service (MTV and Korea)

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

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 is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Position: Senior Quality Specialist, Technical Service (MTV and Korea)

Work Office: Vantive Healthcare Bangkok Office

Responsible Countries: Thailand, Malaysia, Vietnam and Korea

Reporting Manager: Sr. Quality Manager, APAC Technical Service (based in China)

Job Scope:

• Ensure processes and procedures for Technical Service Operations in Thailand, Malaysia, Vietnam and Korea are complying 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 South Korea and MTV.

• 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.)

Job Descriptions:

• Quality support to Field Service operation activities in South Korea and MTV.

• Quality support to Service Center operation in South Korea

• Global Services Quality Systems Local Process Ownership for South Korea and where applicable for MTV: 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 and risk assessment

• For MTV (Malaysia, Thailand and Vietnam) ：

• Support and ensure compliance of field and service center operations processes such as: Device Release, Labelling, Storage areas, Calibration, Decontamination, Equipment Validations, Repair, PM and/or Spare parts management.

• For South Korea: 

• Support and ensure compliance of field and service center operations processes such as: Device Release, Labelling, Storage areas, Calibration, Decontamination, Equipment Validations, Repair, PM and/or Spare parts management.

• Quality KPIs- trending and actions (use of TS systems)

• Local QMR for Technical Service, South Korea and MTV

• Support and/or lead local/regional Service QA and Operational projects/initiatives as required.

Qualifications:

• Bachelor's degree in engineering or equivalent degree in the technical /technology field.

• At least 4 years’ experience in quality management in a medical device or technical service organization – quality processes related to service activity or experience in technical service in manufacturing environment.

• Quality System and Quality Assurance knowledge in operations

• Ability to manage different tasks in an international environment.

• Knowledge of Technical Service processes.

• Ability to understand and troubleshoot technical systems.

• Energetic and able to work independently.

• Good communication, positive attitude, strong interpersonal, negotiation, selling, and presentation skills.

• Good command of written and spoken English.

Benefit & Welfare:

• Base Salary + Allowances (If any)

• Month 13th Fixed Bonus.

• Annual Bonus

• Group Insurance, Flexible Benefits, Annual Leave.

• Etc.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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