Purpose
The Quality Engineer will be responsible for supporting New Product Development (NPD), manufacturing process improvements and achieving strategic quality goals. The candidate will work with the NPD and Operations teams towards meeting customer’s quality, cost, and on-time delivery expectations. In addition the candidate will be responsible for supporting and maintaining the sites Quality Management System in compliance with the following standards and requirements: ISO 13485:2016, ISO 9001:2015
Key Responsibilities
1. To take ownership for the quality of products within Manufacturing Operations according to ISO 9001 & ISO 13485
2. Lead / Drive Customer Complaints from cradle to grave.
3. Lead and/or participate to specific production yield, productivity and customer focused improvement projects.
4. Support new product development activities from concept through launch including guidance to the NPD team as it relates to ISO 9001 & ISO 13485
5. Lead and Provide guidance in conducting structured root cause investigations in manufacturing and at supplier facilities.
6. Support/lead DFMEA and PFMEA activities.
7. Process analysis and improvement through utilization of risk management, statistical tools and six sigma methodologies.
8. Support and where applicable conduct internal and external audits as well as quality performance analysis and reporting.
9. Work with Operations, Purchasing and Supplier Quality Engineering to improve product quality and reduce cost through the utilization of root cause investigation tools such as 5 WHY’s, fishbone diagrams, cause and effect matrix.
10. Provide input into the project Design Inputs, Product Specification Development, and applicable design control documents as defined per Revvity’s product development process.
11. Plan and manage product quality during transfer to production, including design and process validation.
Education and Experience Requirements
12. Applied knowledge of the requirements of ISO 13485 & ISO 9001.
13. Ideally qualified to min. HND level (or equivalent) in an appropriate scientific subject with a min. 3 - 5 years related professional experience within Quality working to ISO 13485 & ISO 9001
14. Strong focus on Continuous Improvement, with demonstrated proven track record of leading problem solving and root cause analysis teams. (Six Sigma or Quality Tools approach)
15. Strong Design Control understanding from concept to launch and a proven track record as quality lead developing and transferring new products to manufacturing.
16. Must be 'customer focused' with passion, energy and drive to continuously improve the way we do business.
17. Must be able to persuade, convince and influence others and develop structured arguments
18. Must be able to work independently and have a proactive approach
19. Must be capable of working under pressure and have ability to get things done
20. Be able to travel both within UK and Overseas as required.