Senior Quality Systems Engineer (Medical Devices) required by market-leading medical devices company in Galway city – to lead key elements of the Quality System to ensure compliance to relevant standards for the business including EN IS013485:2016, FDA QSR and MDSAP. The role will take the lead in ensuring that areas of the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required

Requirements:

  • Bachelors Degree (Level 8) in Engineering, Technology, or Science 
  • 8+ years experience working in a regulated environment
  • Good understanding of EN ISO 13485:2016, MDSAP and FDA regulations
  • Previous people management experience
  • Excellent planning and coordination skills
  • Excellent verbal and written communication skills
  • Excellent attention to detail skills
  • Ability to manage competing priorities in a fast-paced environment
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
  • Ability to prioritize, plan & evaluate deliverables to established strategic goals
  • Ability to interact professionally with all organizational levels
  • Proficiency in use of desktop software applications such as MS office
  • Some travel will be required with the role

Responsibilities:

  • Document control function including co-ordination of DCR process and ongoing compliance, in conjunction with the appropriate resources
  • Assist the quality systems team with the implementation of a new QMS software-based solution
  • Responsible for the record management system and Quality records storage
  • Generation of reports for data trending and analysis of the quality system 
    All phases of the approval process for specific events and investigations
  • Serve as a resource to investigations for conducting root cause analysis and developing and implementing corrective action plans
  • Maintain and manage positive working relationships and ensure appropriate representatives from affected departments are involved
  • Ensure that every activity performed in the QS process is accurately documented and that all timeframes for reporting or resolution are met
  • Complete internal audits and assist in preparation for external audits, as required
  • Aid in generation of management review metrics as required

 emer@emtechrecruitment.ie 

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