NPI Quality Engineer with exprience in the medical devices sector required by multinational in Sligo

Key Responsibilities:

  • Work within a cross functional team involved in the setup, manufacturing and supply of products.
  • Support the Quality Engineering elements of related processes.
  • Maintain the Quality Notification process for the management of CAPA, vendor CAPA, MRB, Customer Complaints, and similar related activities.
  • Main strong relations with our customers.
  • Provide support to the areas of Validations, Metrology, Document Control, performing Internal Auditing.
  • Provide input from a quality perspective to product & process risk assessments, pFMEA.
  • Reporting on GMP compliance in working area.
  • Ensure environmental monitoring is performed and reported.
  • Work very close with the Validation Function to ensure complete transparency and accuracy of validation & verification documentation.
  • Support the following key areas: Initial Quality Assessment, Vendor Selection, Assessment & Qualification, liaising directly with Vendors, Validation Requirements.
  • Provide input from a quality perspective to product & process risk assessments, pFMEA.
  • Pilot Production & Product Approval.
    Identification of ongoing Quality & Regulatory requirements
  • Ensure ongoing compliance, with ISO13485.

Requirements: 

  • BSc. in Quality Management/ Quality Assurance / Engineering or equivalent industry experience.
  • 2+ years experience in a similar role in the Medical Device Industry.
  • Knowledge of ISO, MDD, FDA requirements.
  • Knowledge of Quality Standards, Validation Regulations and Guidance Documents.
  • MS Office proficient. Experience with SAP beneficial.
  • Strong project management capabilities.
  • Excellent attention to detail in oral & written communication.
  • Must be authorised to work in Ireland.

 

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

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