40000-45000 Per Annum
0161 976 3540
over 1 year ago
Location Information - Slough
Salary Circa £45k DOE
A local manufacturer is now looking for an experienced Quality Engineer from the medical device industry to join their team.
Quality Engineer - Key Accountabilities
- Develop, generate and maintain documents to support an effective compliant Quality Management System in accordance with the requirements of BS EN ISO 13485.
- Ensure that our internal and supplier audit schedules are planned, lead and conducted effectively and on time.
- Ensure that effective root cause analysis is conducted for CAPA and complaint investigations in a timely manner.
- Ensure continued regulatory compliance to applicable international regulations and standards
- Initiate, monitor, report and trend across sources of quality data for input to the improvement process and management review
- Conduct process/equipment and computer software risk assessments
- Complete validation protocols and validation summary reports
- Initiate and manage accurate and effective change requests
Quality Engineer - Person Specification
- Must have previous experience in a Quality Engineering, Quality Assurance or Regulatory role in class II or class III medical devices environment.
- An understanding of process validation, process control and statistics and BS EN 14971
- Flexible and able to travel around the UK
- Good working knowledge of Microsoft Office packages
Knowledge of the following is preferred but not essential:
- SAP ERP system
- ISO 14001
- GAMP5 computer system validations
- BS EN 14971
For more information please call Emily Jackson on 0161 976 3540
LEAN Engineering Recruitment Ltd are acting as a 3rd party on behalf of our client. All applications will be held on our database for current and future positions.
We will endeavour to get back to all applicants but if you have not heard from LER within 10 working days then your application has been unsuccessful but please feel free to contact us for an update.