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QA Complaints Specialist

Job Title: QA Complaints Specialist
Contract Type: Contract
Location: Galway
REF: 86540
Job Published: almost 2 years ago

Job Description

QA Complaints Specialist

Our client requires a Complaint Reporting Specialist to support complaint handling and regulatory reporting activities for two business units. This is a 12 month contract based in Galway

  • To coordinate and support complaint handling of product complaints received by Product Experience Management group.
  • To open, track and maintain records for complaints received by Product Experience Management group.
  • Data entry into complaint handling system.
  • To co-ordinate cross-functional activities in the investigation of customer complaints and determination of root cause.
  • To coordinate adverse event reporting per clinical trial protocol requirements and applicable regulations.
  • Support of the Vigilance and MDR programs including adverse event reporting, preparing documentation on adverse events and ensuring timely submission with relevant regulatory agencies.
  • Develop technical product expertise to assess adequacy of complaint information from the field and review of complaint investigations.
  • Support complaint trend analysis and issuance of key reports to relevant departments.
  • Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
  • Support annual Post Market Surveillance reviews.
  • Support responses to Competent Authority queries.
  • Understand and ensure compliance with internal procedures and external global regulatory requirements.
  • Develop processes and systems in line with best industry practice.
  • Actively participate in departmental Continuous Improvement projects
  • Support achievement of department goals and objectives

Education, Experience and Skills
  • Bachelor?s degree (Level 8 NFQ) in Engineering/Science or related discipline
  • 1-2 years relevant experience in a medical devices or related environment.
  • Team player who can work effectively and proactively on cross-functional teams.
  • Experience/understanding of complaint handling or CAPA processes are desirable.
  • Candidates must be a good communicator and are fluent in English, both in writing and speaking.

For further information on this Medical Device Reporting Specialist role in Galway please contact Cliona O?Malley on 091730022 /
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