Quality System Engineer

3 weeks ago

Galway, Galway, Ireland SciPro Full time

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 Role

  • To 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.

Requirements

  • Five 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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