Collins McNicholas

Our client is a well-known global healthcare leader. The Associate Quality Engineer provides a support role to the Quality Manager and will report to the QA & RA Manager. 

This role would be suitable for candidates who have 2/3 years’ experience working as a Quality Technician within a medical device or pharma environment.

Duties and Responsibilities

  • Possesses and applies fundamental and increasing knowledge of Quality, and its application within the company, to the completion of routine assignments.
  • Works in compliance with established procedures and/or protocols. Identifies and resolves readily identifiable, clearly-defined problems.
  • Demonstrates skill in data analysis techniques by resolving missing/incomplete information in routine assignments.
  • Administration and Organization of the QA Mailbox including recognizing where escalation points are required.
  • Compliant distribution – QA approval of Product supporting the interface between commercial organizations/ distribution business and Legal Manufacturers.
  • Compliant warehousing and handling – QA approval of Product disposition supporting the interface between Warehouse Inventory Control and Legal Manufacturers
  • Continuous improvement – Administration, and support of the CAPA/ NC process through weekly continuous improvement meetings.
  • Escalation point for quality-related non-conformances and CAPAs.
  • Execution of product recalls and customer notifications supporting the interface between commercial organisations and Legal Manufacturers.
  • Cross-functional Team member – represents QA in cross-functional teams where business needs require.
  • Support QA structure for company Galway activities.

Education & Experience

  • Minimum 2 years’ experience in the medical device industry, including;
    • Competent working knowledge of recognized Quality Management Systems (e.g. ISO9001/ ISO13485/ ISO14971/ GMP),
    • Awareness of relevant laws and regulations (e.g. CE/ FDA/ PAL)
  • Competency in conducting a technical review of all documentation/ communications.
  • Broad knowledge of engineering and technical applications applied in the development of medical devices useful.
  • 3rd level qualification; minimum level 7.

Salary/Benefits

  • Health Insurance
  • Pension Scheme
  • Generous annual leave allowance
  • Life Assurance
  • Base salary in line with market

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