What you will enjoy doing
1. Supplier Corrective Actions (SCARs): Initiate, manage, and verify effectiveness of supplier corrective actions in response to quality issues, ensuring compliance with FDA and ISO 13485 requirements.
2. Supplier Communication: Serve as the primary quality interface with suppliers to resolve issues, monitor performance, and drive continuous improvement.
3. Incoming Quality Oversight: Support incoming inspection processes by reviewing inspection results, ensuring documentation accuracy, and verifying conformance to specifications and regulatory requirements.
4. Risk Assessment: Collaborate with engineering and quality teams to evaluate the risk of nonconforming parts and ensure appropriate disposition and documentation.
5. Documentation & Traceability: Maintain comprehensive records of supplier performance, inspection results, and corrective actions to support audits and regulatory submissions.
6. Compliance & Improvement: Contribute to supplier development initiatives and ensure alignment with applicable standards such as ISO 13485, FDA 21 CFR Part 820, and EU MDR
What makes you great
7. Bachelor’s degree in Engineering, Quality, Supply Chain, or related field (or equivalent experience)
8. Proven background in supplier quality, manufacturing, or quality assurance
9. Experience of working with Medical Devices, knowledge of medical device regulations including ISO 13485 and FDA 21CFR 820 desired
10. Ideally trained or experienced in supplier auditing techniques
11. Familiarity with quality tools such as 8D, Fishbone, Pareto, and FMEA
12. Demonstrate an understanding technical information, practical technical ability is an advantage
13. Proficiency in data analysis and reporting tools (, Excel, ERP systems)
Why you will love working with us
NOxBOX Ltd, a subsidiary of leading global industrial gases and engineering company Linde, specialises in inhaled nitric oxide delivery and monitoring instruments for the medical market. NOxBOX manufactures and distributes medical ventilators, which can be found in hospitals around the world. These devices are used primarily in neonatal wards and NICUs to support babies and infants with their breathing and have also been relied upon during the global Covid-19 pandemic.
What we offer you!
We are a small team who work together to ensure flexibility for our employees and their families. We offer flexible start times and an early finish on Fridays. We have 25 days holiday + bank holidays. Other benefits include competitive salaries, private health insurance, pension plan, life assurance, and more.