Description
The client is looking to bring on a Quality Engineer with experience within Medical Devices to aid with their CAPA/Complaints, and helping with continuous improvement to update the current systems.Key tasks
- 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 timelines
- 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.
Qualifications, skills and desirable experience
- Educated to degree level or equivalent
- Minimum of 5 years' experience in medical device complaint handling
- Experienced in carrying out product evaluations and complaint investigations is required
- Experienced in Vigilance (MDV and MDR) reporting is required
- Understanding and working knowledge of the Medical Devices Directive 93/42/EEC, ISO 13485, and FDA 21 CFR 803, 806 and 820.
- Must be able to effectively communicate verbally and in writing with all levels of SIW staff, clinicians and other external customers, Notified Bodies and Competent Authorities.
- Excellent Microsoft Excel, Word and Outlook skills are required
- Ability to use initiative and work with minimum supervision is required
- Experience conducting Internal Audits is desirable
Familiarity with medical terminology is desirable