MANUFACTURING QUALITY ENGINEER

MANUFACTURING QUALITY ENGINEER – Roscommon

  • The role is to ensure that the Manufacturing Processes, Products, and Systems are in compliance with the requirements set out in Validations, Customer Specifications, Quality & Manufacturing Specifications, Control Plans, and relevant International Standards as applicable.
  • 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
  • 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 EXPS (Set-Up Sheets) and Standard Operating Procedures
  • The review of Batch Records to ensure the product and Lot History documentation are in compliance prior to QA Final Release.
  • Generation and Revision of EXPS (Set-Up Sheets) and Tube Specifications (Product Specifications) to ensure all relevant Quality and Process/Equipment requirements are captured
  • 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 Vention quality system, 5S, GMP and safety.

 Person Specification:

 

  • The Manufacturing Quality Engineer will have a primary degree or equivalent in polymer, manufacturing or mechanical engineering or have 4 plus years Extrusion Manufacturing or Process Quality/Engineering experience.
  • Medical device manufacturing experience is essential.
  • Hands on experience in extrusion and plastics material knowledge are essential.
  • Must have a good working knowledge of production and quality system requirements in the health care industry (13485:2003 and FDA QSR Parts 820)
  • A Green or Black Belt in Lean Six Sigma would be a distinct advantage.
  • S/he needs strong communication and influencing skills.
  • Have the ability to effectively manage a simultaneous range of diverse activities.
  • Be a self-starter with good motivational and inter-personal skills.
  • A Practical level-headed individual with strong technical ability.
  • Have an ability to work hands-on engaging with cross-functional groups , equipment and materials vendors  to resolve technical issues.
  • A structured approach to problem solving based on the utilisation of data.

For more details please send in your CV in word format and contact Sylvester on 0949029944

Your Recruitment Consultant is Sylvester Jennings

Sylvester Jennings