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Quality Systems Engineer
4 months ago
Orion are supporting our leading medical technology client located in Berkshire on their quest to embed a talented Quality Systems Engineer into their well-established Quality Engineering Department. Headed up by one of the best in the business, this opportunity is primed for you as an individual who is well versed in Quality Engineering within the medical technology sector.
Areas such as MDR, MDD and ISO 13485 will be second nature to you as this opportunity will allow you to be the subject matter expert for the business, to allow them to continually develop and maintain #1 supplier of choice to their customers.
Why should you consider applying for the Quality Systems Engineer?
- A family owned organisation which prides itself on it's humble beginnings and understands the importance of a collaborative and supportive workplace culture. Equally they heavily promote and understand the importance of QA/QE and champion this discipline within engineering.
- 26 Days Annual Leave + 8 for BH
- Private Company Pension
- Employee Recognition Awards - this business are not all about the figures, they have a strong ethos around individuals efforts and contributions
- Hybrid Working - our client has their foot firmly in the 21st Century They are happy to accomodate a hybrid working policy where you can work up to 2 days per week from home.
What will you be doing as their next appointed Quality Systems Engineer?
- Perform internal quality audits in line with their accreditation (ISO 13485) against work instructions, manufacturing proceedures etc.
- Maintain and support their Improvement Culture, using your insight and analysis from performing audits as to were improvements can be implemented
- Play an instrumental part in their CAPA division within their Quality Team, this means that you will take the reigns on investigating non-conformances and collaborate on CAPA objectives.
- Working with the Leadership Teams as well as building positive and effective relationships with other internal stakeholders on QMS related activities.
Ready to apply? This is what you will need to demonstrate;
- Qualified/Certified Auditor for ISO 13485 (please note, this is a deal breaker for our client)
- Hands on knowledge of IS0 3485 i.e. you have worked in medical device manufacturing in a quality engineering role.
- Solid understanding of running CAPA driven activities, therefore you will be able to provide examples of where you have worked on CAPA driven initiatives within medical device manufacturing.
Thank you for your application. Due to the volume of applications we receive, unfortunately we are not able to respond to every application personally, therefore, if you have not heard back from us within 5 working days please assume your application has been unsuccessful. To see our other available vacancies please visit our website.
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