Vantive
Service Quality Engineer (UK/ Ireland & Nordics)
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Service Quality Engineer (UK/ Ireland & Nordics)
Junior Service Quality Engineer | Northampton
About Vantive
Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams worldwide. With a 70-year legacy, our team drives meaningful innovation in kidney care, while advancing our commitment to elevating the dialysis experience through digital solutions and advanced services—extending beyond kidney care to transform vital organ therapies.
At Vantive, we aim to provide greater flexibility and efficiency for care teams while enabling longer, fuller lives for patients. Join a community of focused, courageous professionals dedicated to improving lives globally. Our mission is to extend lives and expand possibilities.
Summary
We are seeking a talented Junior Service Quality Engineer to join our Quality team in Northampton.
The Role
In collaboration with the Quality TS team, ensure processes and procedures for Global Services Operations meet:
- Regulatory requirements
- Our Corporate Quality Manual
- ISO 9001 and ISO 13485 standards
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Key Responsibilities
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Process and Procedure Compliance:
- Enforce adherence to quality standards across UK/Ireland and Nordics clusters, including front-office, back-office, field, and service center operations.
- Ownership of local quality system processes in the cluster:
- Documentation/procedures, training initiatives
- Internal/External audits, CAPA (Corrective and Preventive Actions), and non-conformities
- Post-marketing surveillance (e.g., product complaints, medical device vigilance, field actions)
- Supplier qualification
- Process validation (IQ = Installation Qualification, OQ = Operational Qualification, PQ = Performance Qualification protocols)
- Change control and risk assessment
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Quality Assurance Across Operations:
- Provide support for:
- Global Services field operations (UK/Ireland and Nordics)
- Service center operations (UK)
- Ensure compliance with critically regulated areas:
- Device Release, Labelling, Storage areas, Calibration, Decontamination, Equipment Validations, Repair, PM (Preventative Maintenance), Spare parts management
- Provide support for:
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KPI Monitoring and Improvement:
- Track and trend Quality KPIs (using Baxter QA and Technical Services (TS) systems)
- Identify actionable insights for process enhancements
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Project Leadership or Support:
- Contribute to or lead Local/European/Global projects and initiatives
Requirements
Fundamental
- Proven experience in manufacturing, R&D or quality operations, specifically within the Medical Devices sector
- Desirable to hold a degree in Engineering
- Strong learning-by-doing attitude and problem-solving aptitude
Benefits
Vantive embraces our team’s unique needs: Reasonable accommodations are available for applicants with disabilities. See the linked form for details.
Recruitment Fraud Warning: Vantive investigates fraudulent employment scams. For self-protection tips, review our [Recruitment Fraud Notice](link not linked).
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