The Consultant shall be responsible for, amongst other things:
- Designing manufacturing processes, developing procedures and production layouts for manufacturing, equipment installation, processing, machining and material handling;
- Designing arrangement of machines within the plant facility to ensure most efficient and productive layout;
- Document development work including writing specifications for manufacturing or scientific test results.
- Inspecting the performance of machinery, equipment, and tools to verify their efficiency, and investigating and initiating corrective action of problems and deficiencies to ensure product quality;
- Determine the financial impact of potential decisions and act accordingly.
- Experience in the Medical Device industry;
- Quality systems engineering experience in manufacturing environments
- A critical thinker and active listener with good time management skills in order to work with Suppliers, Production Teams and Project Management teams to define deliverables;
- Strong project management and leadership skills;
- Experience with Advanced Quality Process (APQP) tools and the Metrics to proactively identify and help implement improvements to Quality Systems, Methods, Tools and Processes;
- Experience with Process Failure and Effects Mode Analysis (PFMEA);
- Experience with Design Failure and Effects Mode Analysis (DFMEA);
- Strong analytical problem-solving skills and expert in the use of Non-Conformance, SCAR, CAPA and root cause analysis tools;
- Advanced knowledge of quality related tools including, but not limited to root Cause Analysis
- PQ, IO and OQ validation procedures, test script documentation and audit management.
- 5+ years in a manufacturing environment.
- Experience in setting up a manufacturing facility in the medical sector.
- Bachelor’s degree in Industrial Engineering
- A Master’s degree is advantageous.
EMail applications to Lorraine Nagel : email@example.com
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