Service Quality Engineer (UK/ Ireland & Nordics) in Northampton

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.

We are looking for a talented Junior Service Quality Engineer to join our amazing Quality team in Northampton. The incumbent will:

• In collaboration with the Quality TS team, ensure processes and procedures for Global Services Operations are in compliance with regulatory requirements, the Corporate Quality Manual, and the ISO 9001 and 13485 requirements.
• Actively participate in the design, implementation and/or maintenance of the quality processes in the field service operations and service center operations in the UK/Ireland and Nordics cluster.
• Ensure quality assurance compliance in the front office/back office, field and service center operation processes.
• Maintain a strong relationship with the Global Services team, QATS EMEA team and relevant stakeholders (CQA, SQA etc).

Essential duties and responsibilities:

• Quality support to Field Service operation activities in the UK/Ireland and Nordics cluster.
• Quality support to Service Center operation in the UK.
• Global Services Quality System Local Processes Ownership: documentation/procedures, training, internal and external audit, CAPA and non-conformities, compliance to the 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.
• Support and ensure compliance of field and service center operations processes: Device Release, Labelling, Storage areas, Calibration, Decontamination, Equipment Validations, Repair, PM, Spare parts management.
• Quality KPIs - trending and actions (use of QA and TS systems).
• Support or lead Local/European/Global projects and initiatives.

Fundamental requirements:

• Experience in manufacturing, R&D or quality operations gained within the Medical Devices sector.
• Desirable Degree in Engineering.
• Learning by doing and smart attitude.

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 let us know the nature of your request along with your contact information.

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information.