Collins McNicholas

My client, a multinational in the medical device industry, is looking for an experienced manufacturing quality engineer to join their team. The role is reporting into the Head of Quality.

Responsibilities:

  • Provide regulatory support for new product and support to Operations, Sterilisation and Labelling/Packaging
  • Review and update of Regulatory documentation to ensure compliance with current ISO standards, relevant FDA guidelines and EU Directives
  • Process Audits of the manufacturing lines to ensure the product being manufactured complies with all requirements, and that the Equipment/Process in use complies with the relevant Standard Operating Procedures
  • Identify and suggest improvements to current equipment, processes, and procedures to streamline the manufacturing activities while ensuring high standards of quality
  • In conjunction with the Manufacturing Engineer, provide advice and support to processes that require investigation or development with the goal to improve and make robust
  • Be an active Team Member on Continuous Improvement Projects by delivering on actions committed to, critiquing current methods, and suggesting alternatives/improvements
  • Support the Manufacturing Engineer and cross-functional teams on the collation of data and the resolution of processing issues
  • Actively promote Quality within the Manufacturing group, and assist the Quality Department on introducing initiatives into the Manufacturing Department
  • Lead Manufacturing Driven initiatives with respect to quality within the department
  • Batch Record/Lot History Review to ensure Product Compliance/GMP/GDP are as per relevant procedures prior to final QA Release
  • Maintain effective open communication within the team and foster cross-functional relationships
  • Conduct Training and Competence Assessment with manufacturing personnel on changes being introduced as required

Requirements:

  • Primary degree or equivalent in Engineering/Science discipline
  • 4+ years experience in Medical device manufacturing 
  • Must have a good working knowledge of production and quality system requirements
  • A Green or Black Belt in Lean Six Sigma would be a distinct advantage

For further information on this role please contact Mark on 071 914 2411 or email mark.whelan@collinsmcnicholas.ie

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