MANUFACTURING QUALITY ENGINEER
Manufacturing Quality Engineer required.
Duties and responsibilities:
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 EXPS (Set-Up Sheets) and Standard Operating Procedures
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.
The Manufacturing/Regulatory Quality Engineer will have a primary degree or equivalent in Engineering/Science discipline.
Medical device manufacturing experience is essential, 4 plus years.
Hands on experience in Medical device manufacturing are essential.
A Green or Black Belt in Lean Six Sigma would be a distinct advantage.
For further information contact Maria on 094 9029944 and email CV firstname.lastname@example.org