Quality & Regulatory Engineer required for a permanent role in a growing start-up in Co. Galway. This is an excellent opportunity to be part of an exciting and innovative product line. 

Responsibilities:

  • Support the VP of Quality in managing the Document Control process and the internal audit process, in managing the CAPA process and supporting the Quality Management process
  • Generate and share reports on relevant quality metrics
  • Complete internal audits as required
  • Support regulatory submissions for required markets coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion
  • Support the VP of Quality in managing the Risk Management process for all existing and new products
  • Maintain technical files for all cleared products
  • Complaints handling for medical reporting and filing to the appropriate competent authorities
  • Keep up to date with changing regulatory and compliance requirements 

 

Requirements: 

  • Third level Degree in Quality Assurance 
  • Regulatory experience in medical devices with a certified quality management system
  • Experience of international regulatory processes
  • Knowledge of product certification testing requirements for active Medical Devices
  • In depth knowledge of maintaining a certified Quality Management System
  • Knowledge and application of Quality tools and Methodologies including lean six sigma, TQM etc.
  • Experience of EN/MDD, ISO13485 and FDA requirements
  • Trained QMS Internal Auditor
  • Strong attention to detail
  • Excellent verbal and written communication skills
  • Results orientated and a self-starter with the ability to work on own initiative
  • Knowledge of and commitment to continuous improvement and problem solving
  • Promote best practice and knowledge of the QSR and ISO/MDD standards
  • Advanced Microsoft Office and reporting tool skills
  • Strong project management skills
  • Must be authorised to work in Ireland

 

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

Refer a Friend