We have a requirement for an experienced QA Specialist with working knowledge of standards ISO14971, ISO13485 and regulations IVDR and FDA Part 820. This will be for a specific project expected to be finished in 6 monthsCan be done remotely
* Review the Risk Management Files and update where necessary.* Understand and advise on the Risk Management System of Products ensuring compliance to ISO14971.* Communicate with all areas of the business to ensure completion of Risk Management documentation as required.* Advise and answer any Risk Management enquiries. * Support the wider QA team in ensuring that the quality management system meets all requirements of all relevant regulatory Standards and Regulations.Skills and Experience
- Life Sciences degree
- Knowledge of the application of quality systems
- Able to manage multiple projects, good problem solving skills, good attention to detail, ability to communicate with all levels of staff.
- Experience of working within a Quality Regulated environment
- Working knowledge of standards ISO14971, ISO13485 and regulations IVDR and FDA Part 820 would be a great help
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