Senior Quality Systems Engineer
​Galway

Contract
​€45-€55p/h

SENIOR QUALITY SYSTEMS ENGINEER
The position requires an experienced and proven candidate with a background in Development and Maintenance of Quality Systems, Quality Engineering (including Design Control) and working knowledge on the management and maintenance of Technical Files and Labelling requirements within the Medical Device Industry. The successful candidate will work as part of a team to maintain high quality/performance standards across the company. Reporting to the Senior Quality / Regulatory Manager, the position will be challenging and will require an ability to work autonomously

Roles & Responsibilities
  • Co-ordinate the transition of existing QMS processes, procedures and labelling from the existing company to the Galway based team.
  • Work with Key Stakeholders to lean the current QMS to achieve an efficient QMS
  • Work closely with the notified body to successfully obtain ISO13485 certification
  • Ensure that the necessary updates are communicated to the competent authority, regulatory bodies and customers as changes arise
  • Work with Regulatory Affairs to provide documentation to external customers to support their submissions
  • Support Notified Body / Regulatory Agency / Customer Audits
  • Perform Internal and Supplier Audits 
  • Manage the tracking of the Corrective / Preventive Management Process, working closely to support CAPA leads to successfully implement effective CAPA
  • Manage the tracking of the Non-Conformance Process, working closely with NCR action owners to ensure timely closure of Non-conformances
  • Manage the tracking of the Complaint Handling Process, working closely with Quality Engineers and key stakeholders to ensure timely closure of complaints / manufacturing investigations
  • Manage the tracking of the Supplier Corrective Action Process, working closely with Quality Engineers to ensure timely and effective closure of SCARs
  • Actively participate in the Documentation control process
  • Work with ECN Owners and the Senior QA Assistant/ QC Inspectors to schedule processing of Engineering Change Orders 
  • Develop and maintain documentation in compliance with FDA, ISO, MDD requirements 
  • Initiate / Approve Engineering Change notices
  • Champion continuous improvement through CAPA system, handling of complaints, analysing key performance indicators etc.
  • Collate and trend Key performance indicator data ​

Role Requirements
  • Minimum of degree level 8 in manufacturing engineering, quality engineering, life science or related field 
  • Minimum of 6 yrs. experience within the Medical Device Industry 
  • Proven record in the Development and Maintenance of Quality Systems, Quality Engineering (including Design Control) and management and maintenance of Regulatory Files and Labelling
  • Quality Certification and Lead Auditor Certification while not mandatory would be an advantage