Support process validation strategy and write and execute engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation)
Develop and implement control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
Develop and implement appropriate process monitoring and control methods consistent with the level of process/product risk
Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits
Ensure the development of a comprehensive risk management plan for the product and process
Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities
Responsible to originate/oversee/assist in the creation & release of change orders (COs) through Agile PLM software
Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints
Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree
Profound experience in quality engineering is required
Experience with ISO 9000, ISO 13485 and GMP
Experience in Design and Process Validation
Quality Tools Knowledge
Previous experience working in a regulated industry, such as Medical Device is preferred
Six Sigma or Lean Sigma certification or profound experience preferred
Experience with packaging, Laser, and CNC processes and equipment, preferred
Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity
Projektdauer: 8 MM++
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