SciPro are currently supporting a Medical Device company based in County Galway with their search for a part-time Quality Systems Engineer. This role is 16 hours per week, and is a remote position.Your role will be to implement and maintain the current QMS, to ensure that company activities are performed in a way to assures product quality, as well as meets regulatory requirements.The RoleTo ensure that Quality Systems are compliant with, the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485 & ISO 14971.Complete GAP assessments & associated activities for QMS regulations.Act as Coordinator of the CAPA process, coordinating CAPA activities, including review & approval of CAPA reports.To Maintain the Supplier Approval process. This includes supplier selection, approval, monitoring and reporting.Support Continuous Improvement within the companies current QMS processes.Support R&D and Design Assurance in development activities.Act as a contact for other departments providing quality oversight to ensure compliance and promote quality improvements.Provide backup support to Operations Quality as required.Provide support for other Quality Systems activities, e.g. Audit Management, QMS Regulation gap assessments, SOP Updates, Document System Management etc.RequirementsFive years’ relevant experience in the medical device or pharmaceutical industry.Experience in Class III medical device requirements, ISO 13485; 21 CFR 820; and MDD/MDR as well as Quality Management Systems.Experience in management of Quality Systems activities, in particular Complaints, Risk Management, Supplier Controls and CAPA is desirable.Training in Quality Systems, Risk Management, Complaint, Medical Device Regulations and CAPA management desirable.Please apply within or email a copy of your CV to e.lentell@sciproglobal.com
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