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Job Location | Chippenham |
Education | Not Mentioned |
Salary | £35,000 - £45,000 per annum |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent, full-time |
Are you looking for a business that you can grow and develop with Are you happy working in a multifunctional position, liaising with different teams dailyAt the cusp of commersialisation, this Medical Device client are looking to on board a Quality Engineer to work closely with the R&D and QA/QC teams.If you have worked in a Quality Engineering position before then you will know what is involved.- You will guide colleagues on the design and development activities as well as verification and validation protocols to ensure all processes meet the required regulations (ISO 13485:2016 and 21 CFR Part 820) and lead process improvements throughout the manufacturing operations.- You will identify non conformances, complaints and CAPAs relating to the product ensuring they are processed correctly and answered in a timely manor.- You will also be responsible for overseeing the Design History Files and Risk documentation, reviewing and approving records and digging deeper when needed to look at root cause for any deviations.The team are growing and by the time you start the role, you should sit within a team of 4 people across QA, but also be supporting the wider R&D team on-site too.As the company are still young, you are able to be at the forefront of the decision making process and help sculpt the team and decisions going forward.You will definitely need to have a background in Medical Devices to be considered and if you have a degree within Engineering or Biochemistry then even better.Personality is also very important in this business. They care about culture and having the right person for the role. Given the nature of the position, being a self starter is key and also being unafraid to make decisions whilst being diplomatic in your approach is key.If this role is of interest and you have believe you have the relevant experience, please get in touch as interviews will be happening within the next week. Required skills
Keyskills :
Manufacturing Medical Devices Process Control Validation quality engineer