This well-established medical device company in the midlands are looking for a senior quality engineer to join their operations. In this role you will be the primary contact for liaison with Competent Authorities and management of communication with Competent Authorities primarily focusing on complaints and vigilance activity, while also acting as team lead for international PMS complaints group.
Key responsibilities will include (but are not limited to) the following:
Established internal primary point of contact for post market surveillance/Competent Authority Liaison for Complaint and Vigilance (and other as required) Queries (Management of Timely responses)
Lead PMS complaint handling group in day to day activities
Coordinate systematic collection of internal and external data on product safety and performance to support Complaint File investigations and closures
Coordinate and facilitate cross-functional product/complaint file reviews as required to support complaint activity
Ensure effective CAPA is taken to help prevent reoccurrence
Final Reviewer/Approval for closure of all Complaint files/Management of file closures to meet Metric Requirements
Provide periodic training for company personnel on the company’s post market surveillance processes and procedures (complaints/vigilance)
Collaborate closely with other sites to share best practices and pro-actively drive improvements in the post market surveillance approach
Support the provision of trend data as required
Provide support for the risk management process and provision of complaint data to risk management groups
Support other activities in the post-market surveillance system as it develops.
Assist in developing and implementing global policies and procedures
Perform all other work related duties
ESSENTIAL SKILLS / EXPERIENCE
Degree or equivalent with 3/5 years’ experience medical device environment.
Experience in Post-Market Surveillance with experience in Complaint Handling/Vigilance Reporting – essential.
Previous supervisory/management experience, desirable.
Excellent technical writing experience within a medical device environment – essential
Good working knowledge of the Medical Device Directive and familiarity with its transposition into national legislations within Europe as it affects complaint management.
Good working knowledge of the Quality System Regulations as they pertain to customer complaints.
The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management.
Experience with bio-hazard management/contamination control preferred- Not essential.
If you would like further Information you can contact the recruiter directly:
Kevin Silke | Tel: +353 (0) 1 507 9255