Collins McNicholas

Our client, a leading Medical Device company in Sligo, is looking to hire a Quality Engineer. 

Responsibilities:

  • Be part of a cross functional team involved in new product introductions
  • Provide input from a quality perspective to product & process risk assessments, pFMEA
  • Perform and provide support to validations, metrology, document control, internal auditing
  • Interact directly with vendors and customers
  • Liaise with other departments as required as part of day-to-day activities
  • Perform process control monitoring & improvement activities
  • Work & report on CAPA, vendor CAPA, MRB, customer complaint activities
  • Support all steps of the change control and NPI processes, mainly:
    • Initial quality assessment
    • Vendor selection assessment and qualification
    • Validation Requirements
    • Provide input from a quality perspective to product & process risk assessments, pFMEA
    • Pilot Production & Product Approval
    • Ongoing Quality & Regulatory requirements

Requirements:

  • Third level qualifications in Quality, Engineering, Science or related discipline
  • Minimum 3 years in a similar role in the medical device industry
  • Knowledge of ISO 13485
  • Demonstrated track record in a similar role
  • Excellent attention to detail and accuracy
  • Excellent oral & written communication skills

For a confidential discussion and a more detailed job description, please contact Mark Whelan on 071 914 2411 or email mark.whelan@collinsmcnicholas.ie 

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