Senior Medical Devices Quality Engineer with experience in medical devices required by growing multinational in Galway city. Reporting to the Quality Operations Manager, you will lead a team of 6 in maintaining high quality performance standards within a Lean Six Sigma / FDA / ISO 13485 environment.

Responsibilities:

  • Supervision and direction of a team of six
  • Lead and drive QA initiatives 
  • Provide Quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions
  • Lead, coordinate & maintain risk assessment documentation e.g. FMEA’s
  • Investigate root cause of Quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues
  • Strategically lead new product introduction and contract reviews from a QA perspective
  • Prepare and update Operations procedures and associated documentation
  • Overall responsibility for functional area GMP standards and compliance including the promotion of Quality awareness
  • Establish inspection standards, sampling plans, and test methods
  • Report Quality metrics
  • Develop strong links with customer organisations and other project stakeholders
  • Quality review of functional area validation documentation
  • Perform and support internal and external audits to ISO and FDA requirements
  • Perform an active role in further development and continuous improvement of the Quality Management system

Requirements:

  • Level 8 Degree in Science / Engineering or related fields
  • Minimum of 5 years Quality Engineering experience in a medical device manufacturing environment
  • 3 years experience in a senior quality engineering role
  • Experience leading a team 
  • Strong CAPA experience
  • Strong root cause analytical and problem-solving skills
  • Clear understanding of medical device quality systems and requirements, including measurement techniques, would be a distinct advantage
  • Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable
  • New product introduction and manufacturing process transfer experience desirable
  • Demonstrated excellent organizational skills and ability to work on own initiative essential
  • Excellent written and verbal communication skills essential

 

Please contact Emer Smith to discuss in confidence
00353578638188       
emer@emtechrecruitment.ie

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