Test Method Validation Quality Engineer
Location: Colorado Springs, CO
Duration: Until the year end
The Test Method Validation Quality Engineer will be responsible for determination of suitability of SPNC test methods for their intended use and validation of such methods, primarily in te Recieving Inspection area
What Success Looks Like:
• Lead continuing Test Method Validation and Measurement System Analysis efforts
• Must be able to interface well with others, especially Production supervisions, Manufacturing Engineering and R&D Engineering
• Must have excellent data entry, technical writing, statistical analysis and documentation skills
• Must have familiarity wide variety of test equipment from CMM/Vision systems to simple handheld measurement tools.
• Follow established validation strategies so that all appropriate requirements are being met from planning, protocol definition, leading execution of protocol, analyzing and reporting results and defining procedures and training requirements, completing report and gaining approval to close
• Ensure methods meet the requirements of ISO/IEC 13485, ISO/IEC 17025, as well as other worldwide regulatory agencies
• Determine and recommends sampling plans, equipment requirements, measurement techniques and training requirements that will assure specific quality levels.
• Partner with engineering in selection of measurement equipment and fixture design ensuring appropriate accuracy and precision for processes to be measured
• Develop, implement and monitor SPC on critical processes. Communicate status and progress
• Develop systems for monitoring measurement system capability. Recommends and assist, as necessary, in the implementation of corrective/preventative actions
• Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification
• Guide with inspection and testing techniques; read and interpret blueprints
• Typical experience required is a minimum of 5 years as an Engineer in a related field, BS in Statistics, Mathematics, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline, preferred.
• Solid experience with Test Method Validation and Uncertainty Analysis
• Experience with leading problem-solving, root cause analysis and conducting Corrective and Preventive Action processes
• Regulated industry preferred
• Statistical analysis, Minitab software preferred
• Proficient in the use of various measuring tools and troubleshooting equipment
• Strong mechanical aptitude