Quality Manager - Medtech And Healthcare

SIGMAR RECRUITMENT

GALWAY

Quality Manager - Medtech and Healthcare. Work as a member of senior leadership onsite for a growing Medical Device, Diagnostics and Healthcare company. This is a maternity cover looking for someone to assist the site manager. This role will report to the Plant manager and there are 25 people on-site in Galway and 300 people across their other sites in Ireland. This company provide vital diagnostics, rehabilitation products and healthcare products for patients globally. Requirements: Manage KPIs and other stakeholders to ensure that supplier quality, customer quality and operational quality activities are all compliant and highly efficient. Prepare short and medium term plans and strategy for the site in line with other departmental plans and activities. Act as the leader for customer and regulatory audits. Ensure site compliance to all relevant regulatory requirements. Manage and develop validation protocols and change controls. Oversee site risk management. Manage pharmacovigilance activities. Provide technical support to the QC Lab. Coordinate internal audits and ensure QMS and quality documentation is maintained. Oversee CAPAs, NCRs and deviations investigations. Requirements: Essential: Level 8 degree with 5 years or more experience in lab or quality team management within a highly regulated environment. Leadership experience. Experience in a regulated pharmaceutical/medical device industry, preferably in a Quality function. Experience in Risk management, Supplier Management, Customer Complaints, investigation techniques and root cause analysis. Desired: HPRA/FDA audit experience. ISO17025 experience. Microbiology background. Knowledge/Experience in Post Market surveillance and pharmacovigilance. Knowledge/Experience in Validation and Sterilization. To apply for this position please contact James Porter at Sigmar RecruitmentT: +353 91 455305E: jporter@sigmar.ie. All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent. Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.

1347 days ago