Senior Quality Specialist

Hrm

Position: Senior Quality Speci, Dublin

This organisation are considered the leading global biotechnology company focused on developing therapies for individuals suffering from rare diseases worldwide, along with medical devices and in-vitro diagnostics. The organisation have a global headcount in excess of 22,000 employees and generate revenues in excess of €11 billion. The organisation is expanding rapidly within Ireland and as such, they require a Senior Quality Specialist (Medical Devices Complaints) to join their team. This is a permanent position which will be based at their corporate HQ in Dublin. The Position. As the Senior Quality Specialist (Medical Devices Complaints) you will be required to be the SME for medical device and combination product complaints on a global scale. Along with this, you will be responsible for; Coordinating investigations into complaints, monitoring timelines and associated CAPAs that have been implemented. SME for regulatory requirements relating to medical device and combination products for the organisation globally. Interacting with, and providing an oversight of, CMOs used by the organisation at various stages of medical device production. The Person. The successful Senior Quality Specialist (Medical Devices Complaints) will need at least 3-5 years experience within the medical device / diagnostics industry sector, 3 years of which should be within a customer complaints / regulatory position. Extensive knowledge of ISO 13485 and EU, US and International medical device regulations is required for this position. This role offers an excellent remuneration package along with superb working conditions. To learn more apply online or call Conor Britchfield at HRM on 353 1 6321870. This job originally appeared on RecruitIreland.com.

2204 days ago