Manufacturing Quality Engineer

  • Act as the Manufacturing Lead with respect to the thorough investigation of Non-Conforming Materials and Complaints, using Data Analysis/Problem Solving Techniques to arrive at Root Cause and identify Corrective & Preventative Actions to prevent recurrence
  • 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
  • Ensure that all products manufactured meet the specifications, performance & quality criteria of end users, customers, regulatory authorities and the company.
  • Maintain work areas, equipment and supplies in a manner which conforms to the requirements of the quality system, 5S, GMP and safety.

Your Recruitment Consultant is Sean Winstanley

Sean Winstanley
Sean joined Arcon Recruitment in early 2018 as our Specialist Technical Recruiter. Originally from the UK, now settled in Ballaghadrereen, Sean brings a wealth of recruitment experience in the IT / Technical arena. Sean has developed excellent skills account managing international, high profile clients solving their recruitment dilemmas.