GBUK Group is a Yorkshire based medical device provider specialising in the design and supply of high-quality products that support safe and effective patient care. With a strong emphasis on innovation, clinical performance, and regulatory excellence, GBUK works in close partnership with healthcare professionals to deliver reliable solutions used across hospitals and community care settings in the UK and internationally.
We are looking for someone to join out Quality team initially on a six-month temporary contract basis to enhance our Quality Team at our Selby site. A full driving licence and own car is essential as there are no public transport links to our site.
About The Role
Reporting to the Quality Manager, this key role is responsible for working within the Warehouse, to perform the required tasks to ensure compliance and quality of our products prior to release to the market, while maintaining conformance to ISO 13485 & 9001 at all times.
Key Responsibilities
Conduct First Article Inspections (FAIs) as required, following the relevant procedures
Raise product and process non-conformities, assisting with investigations and root cause analysis for these as needed. Inspection of impacted product related to NCs.
Raise and inspect any issues found at receipt or within the Warehouse following the non-conformity process & place on hold if required
Preparing rework documentation as required and performing rework activities, whilst liaising with relevant teams and suppliers
Collate and review the necessary paperwork to confirm product has been manufactured in accordance with the correct specification, prior to market release
Generating release-for-sale documentation (including Certificates of Conformity) to allow release of compliant goods.
Provide input into the evaluation of suppliers regarding supplier communication and issues with products.
Essential Experience And Skills
Experience of receipt and inspection activities in a manufacturing environment
Experience of working within a Medical Device (or similar) industry
Good standard of written English with good attention to detail
Computer literate
Able to work as part of a team but also able to use own initiative.
Good written and verbal communication skills.
Good organisation skills and attention to detail.
Desirable
Experience of product testing
Minimum of GCSE grade "C" or equivalent in Maths and English or relevant vocational training
Equality
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.