Senior QA Manager

hace 4 semanas


Sin especificar, España Life Science People A tiempo completo

Calling all Senior QA Managers, this is a unique opportunity to make real change within the medical device field. I'm working with a client in Spain who is based within the Medical Device field. You will be closely working with the CEO and senior management to make real change in a company who pride themselves on innovation, excellence, quality and passion. Description - Maintaining, implementing and monitoring Quality Management Systems in line with company standard.Ensuring continuous Improvement and compliance with company quality systems. Enabling the client to remain compliant with - ISO3485, FDA regulation and any other legislation within the companies area of development.Review technical documentations, take part in the release of the product and work with External, Internal audits, Subcontracted manufacturers and Health authorities. Ensure training to staff on quality issues and budget management of quality department.Encompasses work of Post Market Surveillance Manager - Responsible for the post market surveillance system and ensure compliance.Manage and plan FSCA (Field Safety Corrective Actions) and report them to the relevant authorities and notified bodiesAct as Management representative - Document processes needed for Quality Management systemReporting to senior management - Updating them on the effectiveness and potential Improvement on the Quality Management System. Requirements - Degree level in - Science, engineering, health sciences or similar fields.Spoken and Written English - to a high level.8 years within quality preferably in the medical device field 5 years experience as an internal auditor3 years experience in market surveillance Desired skills -Internal auditor certificate in ISO 13485FDA 21 CFR 820 Knowledge Knowledge of document management software Training in Regulatory Affairs or Pharmacovigilance.


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