Service Quality Engineer (UK/Ireland & Nordics)
Vantive Northampton, England, United Kingdom
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.
Responsibilities
* Ensure processes and procedures for Global Services Operations are in compliance with regulatory requirements, Corporate Quality Manual, ISO 9001 and ISO 13485.
* Actively participate in the design, implementation and/or maintenance of quality processes in field service operations and service centre operations in UK/Ireland and Nordics cluster.
* Ensure quality assurance compliance in front office/back office, field and service centre operation processes.
* Maintain a strong relationship with the Global Services team, QATS EMEA team and relevant stakeholders (CQA, SQA etc.).
* Provide quality support to Field Service operations in UK/Ireland and Nordics cluster.
* Provide quality support to Service Centre operations in UK.
* Own Global Services Quality System local processes: documentation, training, internal and external audit, CAPA, non-conformities, post-market surveillance activities, supplier qualification, validation processes, change control, risk assessment.
* Support and ensure compliance of field and service centre operations processes: Device Release, Labelling, Storage, Calibration, Decontamination, Equipment Validation, Repair, PM, spare parts management.
* Track Quality KPIs and take actions (use of Baxter QA and TS systems).
* Support or lead local, European, and global projects and initiatives.
Qualifications
* Experience in manufacturing field, R&D or quality operations.
* Desirable degree in Engineering.
* Learning by doing and smart attitude.
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 here and let us know the nature of your request along with your contact information (Form Link).
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