Service Quality Engineer (UK/ Ireland & Nordics)

Vantive; Northampton; On-site; GBP 35,000 - 55,000

Job description

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 Service Quality Engineer to join our amazing Quality team in Northampton.

Summary

• Ensuring processes and procedures for Global Services Operations are in compliance to regulatory requirements, to Corporate Quality Manual and to 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 UK/ Ireland cluster and Nordic countries.
• 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).

Duties

• Quality support to Field Service operation activities in UK/ Ireland cluster and Nordics countries.
• Quality support to Service Center operation in 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 Baxter QA and TS systems).
• Support or lead Local/ European/ Global projects and initiatives.

Education

The function requires a degree in biomedical sciences/electrical or electronic engineering/technology subjects would be advantageous.

Experience

2-5 years proven experience in quality management in the medical device environment. Established experience in quality management in the medical device environment would be ideal, but open to experience in technical service/ manufacturing/ R&D environment. Expertise in Medical Device or Electro-mechanical products would be an advantage.

Competences

• Good Quality System and Quality Assurance knowledge in an operational environment.
• Strong knowledge of ISO 9001 and 13485 standards.
• Strong organisational & prioritisation skills in an international environment/stakeholders.
• Strong communication skills and attention to detail.
• Previous experience in managing compliance (conducting NCR/CAPA investigations, collaboration with Post Marketing Surveillance teams, conducting Risk Assessments...).
• Travel and overnight stays across the UK, and occasionally within Europe.
• Strong written and verbal communication skills.
• Excellent/High attention to detail.

Technical skills

• Medium Knowledge of Electromechanical Medical Devices.
• Successful experience on implementing continuous improvement by standardization in complex environments.
• Good problem solving skills.
• Demonstrable project management skills.

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.

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