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West Pharma Quality Specialist Complaints 
Ireland, Dublin 



  • Must have a third level qualification in Engineering/Quality/Science.
  • Must have 2+ years work experience in a Medical Device manufacturing environment.
  • A working knowledge of quality systems such as ISO 13485 is essential. Experience and knowledge of 21 CFR Part 820 and EU GMP is an advantage.
  • Team player who can work effectively and proactively on cross-functional teams.
  • Experience/understanding of complaint handling or CAPA processes are desirable
  • Must have excellent communication skills both oral and written.
  • Auditing experience to the requirements of ISO 13485 / EU GMP / 21 CFR Part 820 is preferred.

Essential Duties and Responsibilities:

  • To coordinate and support complaint handling of product complaints received by customer
  • Interface on an ongoing basis with customers to ensure requirements / concerns / complaints are communicated and corrective and preventive actions are closed in a timely and effective manner.
  • To open, track and maintain records for complaints received by customers.
  • Data entry into complaint handling system.
  • DHR review of Medical Device to be conducted within the QMS
  • Lead investigations into customer / material / product issues to ensure a thorough root cause, containment / corrective and preventive action is implemented.
  • 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 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.
  • Executing internal process and system audits.
  • Manage quality projects in support of continuous improvement eg. Lean Projects.
  • Ensuring the timely and effective closure of day-to-day complaints issues.
  • Interface with other departments on a daily basis.
  • Coach and drive a culture of compliance and continuous improvement.
  • Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
  • Compliance to all site Environmental, Health and Safety requirements, training and regulations.
  • Compliance to all local site company policies, procedures and corporate policies.
  • Perform additional duties at the request of the direct supervisor.