Description
Real Staffing are recruiting an exciting new position for a Medical Device Company based in London with a salary close to £45,000.The ideal person will have:
- - Experience in medical device complaint handling.
- - Experience carrying out product evaluations and complaint investigations.
- - Experience of Vigilance (MDV and MDR) reporting.
If this is you...
As a Complaints and Vigilance Engineer you will join a vibrant and busy Quality department, focusing mainly on ensuring all complaints are investigated throughout, supporting complaint investigation reports and Providing support and representation of the complaints department for Post Market Surveillance and Risk Management Programs.
Based in London, this career opportunity is easily accessible via car or public transport, with the Central Line providing a direct link straight into the heart of our capital.
The company itself is a pleasure to work for, with a very dynamic culture of friendly, hardworking individuals.
Your general responsibilities will be to:
- - Ensure all complaints are fully investigated; review associated manufacturing records, complaint data/identifying trends and risk documentation.
- - Carry out root cause analysis, analysing returned product samples against specifications and sending ex plants out for retrieval analysis
- - Support the reporting of complaint investigation outcomes to regulatory authorities and customers within a timely manner.
- - Ensure corrective actions (including field actions) are raised where necessary and providing support to CAPA owners/systems, when required
- - Provide support and representation of the Complaints Department for Post Market Surveillance and Risk Management programs.
Tasks you will be undertaking include:
- - Ensuring that all complaint processing is carried out in line with the procedures
- - Completion of product evaluations
- - Completion of complaint investigations and coordination of retrieval analysis activities ensuring actions are finalised within set time lines
- - Trending complaints by use of the complaints database
- - Providing support to the Complaints & Vigilance Administrator to ensure the correct information has been requested, when required
- - Escalate issues to the Complaints & EC Vigilance Manager when they arise
- - Creation and submission of vigilance reports to appropriate regulatory bodies in a timely manner, when required
- - Assisting with and creating relevant documents for Health Hazard Evaluations and Field Safety Corrective Actions/Recalls
- - Deputising for the Complaints & EC Vigilance Manager when required
- - Supporting the internal audit programme by carrying out audits, as directed
- - Any other tasks or duties that are deemed appropriate by your line manager.
Your Skills/ Qualifications and Experience will include:
- - Being Educated to degree level or equivalent
- - Having a minimum of 5 years' experience in medical device complaint handling
- - Experience carrying out product evaluations and complaint investigations is required
- - Experience of Vigilance (MDV and MDR) reporting is required
- - Understand and have working knowledge of the Medical Devices Directive 93/42/EEC, ISO 13485, and FDA 21 CFR 803, 806 and 820.
- - Being able to effectively communicate verbally and in writing with all levels of SIW staff, clinicians and other external customers, Notified Bodies and Competent Authorities.
- - Having Excellent Microsoft Excel, Word and Outlook skills.
- - Having the ability to use initiative and work with minimum supervision.
- - Experience conducting Internal Audits.
- - Familiarity with medical terminology.
If you think this sounds like the ideal role for you and you have EU Citizenship status, please contact me as soon as possible as a high volume of applications are likely to come through this week.
Phone:
Linkedin: https://uk.linkedin.com/in/marvin-trenchfield-980686b7