Senior QA Specialist
Hrm
Title: Senior Qa Specialist (M, 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. They are expanding rapidly within Ireland and as such they require a Senior QA Specialist (medical devices) to join their team. This position is an 11 month contract and will be based at their corporate HQ in Dublin. The Position: 11 Month Contract. As the Senior QA Specialist (Medical Devices) you will be required to provide Quality and Regulatory Compliance support for Medical Devices and In-Vitro Diagnostics, with a focus primarily on the EU. Additional responsibilities will include; Maintaining compliance of global quality standards against changing device and IVD regulations particular the EU MDR and IVDR and associated legislation. Coordinating management reviews, post market surveillance, DHF audits and independent design reviews as required. Supporting maintenance of product compliance to CE marking requirements. Supporting EU medical device complaints including vigilance assessments. The Person: The successful Senior QA Specialist (Medical Devices) will require 3-5 years experience within a Quality role in the medical device/diagnostics industry sector, with a working knowledge of ISO 13485 standards. An in-depth knowledge of EU, US and international regulatory standards for medical devices/in-vitro diagnostics is preferred. A University degree or equivalent in Science, Engineering or an equivalent technical discipline is also required. This role requires excellent attention to detail, along with strong verbal and written communication skills. The successful candidate will also possess strong decision-making capabilities. 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.
2257 days ago