Address
Form of work
SalaryOur client are a medical device diagnostics company that is transforming community-based healthcare. The company manufacture innovative products are being in numerous settings to diagnose and monitor wellness as well as disease. The company has on the market and in development 30+ tests.
They are looking to add a Quality Engineer to the team, responsible for reviewing documentation and records primarily associated with instrument manufacturing & QC test release processes in line with the QMS. Provide QA oversight, guidance and training in all quality operations activities associated with these activities.
Skills:
The Quality Engineer will be responsible for DHR creation / maintenance, batch record review and product approval for instrumentation
DMR maintenance for instrumentation
Provide QA over-sight, guidance and training for quality assurance activities associated with Instrument Operations
The Quality Engineer will be the QA representative for review and approval of the following as required:
- Documentation change requests
- Quality Events
- Planned Deviations
- KPI / metric generation and reporting providing inputs to site leadership, audits and management review ensuring visibility of progress and status
- Identifying opportunities for process improvements and support the implementation of improvements
- Preparing and creating documents and records for upload to the document management system
Knowledge:
- Quality / Regulatory Compliance
- Knowledge and experience of working to ISO13485:2016 & FDA 21 CFR Part 820
- Relevant experience in DHR review/release and nonconformance management
- Ability to use problem solving tools and methodologies
- IT and System skills
Qualifications:
- Ideally Bachelor's degree or equivalent level attained through relevant experience considered
- Hybrid working may be available if needs be
To find out more about Real please visit (url removed)
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC(phone number removed) England and Wales
