Quality Engineer 273906
Siemens Healthineers is seeking a talented and experienced Quality Engineer to join our Healthcare Diagnostics business based at the well-established and modern facility in Llanberis, located next to Snowdonia National Park. This Quality Engineer role comes with an attractive salary and the chance to join a collaborative and inclusive company.
This role is split between our site in Llanberis and home working.
In this engineering role, you will ensure compliance with ISO 13485:2016, ISO14971:2019, FDA 21 CFR Part 820, and other international regulatory requirements including IVDD and IVDR compliance. You will focus on supporting internal and supplier validation activities, risk management, and supplier quality assurance.
If you were already working for us in this Quality Engineer role, here are some of the things you would have done last week:
- Support internal validation projects of equipment purchased product and software in line with GAMP guidelines and global procedures
- Control supplier quality activities and validations
- Provide QE support
- Support annual update of risk files
- Independent review for the control of nonconforming product/systems and CAPA
To succeed in this flexible role, you should be trained to lead auditor level and have an understanding of QA processes, together with the ability to influence at all levels of the organisation.
If this Quality Engineer job in Llanberis sounds like the right fit for you, then please apply today. We look forward to hearing from you.
Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience, and digitalising healthcare. We embrace and encourage different viewpoints, backgrounds, experiences and encourage our employees to be themselves and empower them to unleash their true potential. This allows diverse ideas and inclusive approaches to thrive every day
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Products Ltd
Experience Level: not defined
Job Type: Full-time