Senior Supplier Quality Engineer with 5+yrs experience required by market-leasing medical devices company in Galway city to lead quality engineering activities within supplier controls and project teams 

Requirements:

  • BE/BS/BA Degree
  • 5+ years Quality Engineering experience or related role within the medical device industry
  • Thorough understanding of ISO 13485 and FDA QSR standards
  • Ability to work on own initiative
  • Strong team member with the ability to identify and drive implementation of innovative quality improvements
  • Ability to work within project teams, consistently meeting deadlines and ensuring that all actions are being addressed appropriately
  • Demonstrate and actively promote high levels of professional quality engineering
  • Good communication skills with the ability to liaise with suppliers, customers and regulatory contacts in an informed professional manner
  • rocess Validation knowledge
  • Good administrative/organizational ability with high level of attention to detail

Advantageous:

  • Post-graduate qualification in Quality Assurance is preferable although not mandatory

Responsibilities:

  • Support Quality Management in the development of key objectives and strategies to ensure continuous growth of personnel and quality systems improvements
  • Manage and lead all process validation activities including IQ, OQ and PQ with existing and new Suppliers
  • Ensure effective and timely closure of Quality System documentation 
  • Support the implementation of and maintain compliance to supplier, Distributor and 3PL EU MDR requirements
  • Lead Quality Engineering support on project activities i.e.: Design Improvements, Supplier Transfer’s, Cost Improvements, and New Product Introductions etc.
  • Lead Supplier Approval and Supplier Management Activities and manage Supplier Quality assurance process for allocated Suppliers to ensure Supplier Approval Requirements are met
  • Work with Manufacturing Quality to establish inspection plans, frequencies, and test methods for incoming material/parts
  • Champion continuous process improvement and, in conjunction with other functions, analyse feedback and identify and implement appropriate problem solving and statistical techniques to improve quality of manufactured product and overall effectiveness and efficiency of processes
  • Overall responsibility for GMP standards and compliance within Project Teams and Supplier Engagement
  • Maintain compliance with ISO and FDA Quality System regulations
  • The role will also support external audits, internal audits and any relevant Quality/Regulatory compliance related activities as deemed necessary
  • The role will require a high degree of flexibility to coordinate the variety of tasks

 emer@emtechrecruitment.ie 

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