Permanent
Complaint Investigator
Inchinnan

Complaint Investigator

Ref: 83| Posted: 28th Nov 2022

Terumo Aortic are currently looking to recruit a Complaint Investigator to join our busy and expanding quality team. This is an exciting role that offers individuals the chance of career progression and to add to real value to the business.

The main responsibilities of the role are;

  • As part of a dedicated Complaints function, develop and maintain all aspects of the Complaints management process
    • Conduct, evaluate and provide guidance on effective complaints investigation, root cause analysis, and general good complaint practices, ensuring that complaints are comprehensively structured and documented
    • Utilise Impact Assessment process to effectively escalate complaints as appropriate to CAPAs
    • Support other functions in the development of comprehensive and time bound Investigation and Action Plans
    • Generate and maintain trending data for the complaints process
    • and publish as part of QMS KPI dashboard
    • Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers
    • Provide audit support to demonstrate compliance within the complaints process
  • Work collaboratively with other functional areas to effectively investigate and resolve complaint issues, deploying appropriate tools to assist root cause analysis and risk assessment
  • Work with other functional areas to identify appropriate containment actions for existing inventories
  • Provide appropriate traceability reports to determine the extent and scope of complaint issues and communicate any required quarantine/control actions within the company and to Distributors as required
  • Assist in communications with regulatory bodies and Competent Authorities
  • Assist in the effective management and communication of Field Safety Notices, Initial, Intermediate and Final Device Vigilance Reports and recall communications as required
  • Perform duties associated with the maintenance and improvement of the complaints process ensuring compliance to all relevant regulatory standards

The successful candidate will possess;

  • Degree or Higher National Diploma preferred in an Engineering, Science or Quality discipline or relevant Clinical or Nursing experience
  • Experience working within a Complaints function or in regulated manufacturing / engineering /production environment preferably in medical devices
  • Knowledge and understanding of applicable regulations especially with regards to complaints and MIR/MDR reporting
  • Experience working within a complaints function or other relevant GxP experience preferably in medical devices
  • Experience of Medical Device Directive and related regulations, preferably for Class III devices
  • Strong analytical and problem-solving skills
  • Excellent communication and presentation skills