Connecting...

Senior Quality Engineer, Post Market Surveillance

Job description

In this job, you will work within the Divisional Post Market Surveillance team, supporting and and guiding the Business Units in discharging their regulatory obligations to conduct Complaint Handling, Vigilance reporting and Post Market Surveillance activities.   

 

Responsibilities and Duties:

  • Contributing within the Divisional Post Market Surveillance team - a geographically dispersed team of quality and data analysis professionals.
  • Possesses and applies excellent knowledge of Quality, and its application to Vigilance Reporting, Complaint Handling and Post Market Surveillance
  • Support Global Business Units in Complaint Handling, Vigilance Reporting and Post Market Surveillance activities.
  • Obtain an in-depth knowledge of ARDxs global operations and structures which will enable you to make informed decisions and provide direction to BU Quality and Regulatory teams and others
  • Applies problem-solving skills to creatively respond to complex situations, work that requires processing and interpreting, more complex issues. Identifies problems and possible solutions, taking appropriate action to resolve. Demonstrates skill in data analysis techniques and resolving problems within an environment of  incomplete information
  • Seeks consensus for decisions to produce effective end results and applies risk assessment techniques.
  • Embraces and leads continuous improvement practices
  • Responsibility for project delivery on behalf of the division and with the support of the Business Units
  • Escalation point for non-conformances and CAPAs

 

Essential Criteria:

  • Third Level Qualification in related field (Science, engineering or nursing)
  • 8+ years of experience in medical device industry with 3+ years of progressively responsible positions, including;
  • Experience with Post market Surveillance (active and passive), including the compilation of periodic reports
  • Working knowledge of Quality Management Systems and Global Medical Device regulations (e.g. ISO9001/ ISO13485/ ISO14971/ cGMP / CE/ FDA/ PAL/IVDR/MDSAP)
  • Experience working in electronic complaint management systems
  • Able to travel internationally (approximately 15% annually)

 

Desirable Criteria:

  • Experience with in-vitro diagnostics products
  • Experience managing customer complaints for medical device or in-vitro diagnostics
  • Broad knowledge of engineering and technical applications within the medical device industry

To apply for this position please contact Keeva O’Shea at Sigmar Recruitment Tel: +353 91 749264 Email:   koshea@sigmar.ie

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent.

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.