Quality Engineer 2

Provide direct and ongoing support to Receiving Inspection in evaluating inspection methods, process improvements, sampling plans, coordination of first article component and fixture inspections, selection and qualification of inspection equipment Work closely with Receiving Inspection, Project Quality Engineers, and Supplier Quality Engineers to develop and implement inspection methods, sampling plans, and related procedures Provide the primary input to the design, development, and implementation of fixtures for measuring component parts in Receiving Inspection Attend assigned design control and phase exit meetings Create vision system CMM programs to semi-automatically measure complex molded component parts and sub-assemblies Develop inspection processes for complex and high-volume component throughput Create and conduct measurement capability assessments (i.e. Gage Repeatability and Reproducibility) Design and develop methods to determine measurement accuracy and precision through testing and analysis Evaluate and determine cause for measurement variation Create test strategies and conduct process/equipment/measurement method qualifications and validations Provide key support in the design and fabrication of mechanical fixtures, tooling, and equipment for component/sub-assembly measurement Measure task/project percentage completion at critical stages and takes appropriate actions as needed to keep tasks/projects on track Plan, manage and prioritizes tasks/projects, tracks progress toward overall goals, and provides periodic updates to management Typically requires a Bachelors' degree in Mechanical Engineering, Manufacturing Engineering, or related field with minimum 2 years of relevant industry experience and/or training Proficiency with inspection equipment such as: CMM (Mitutoyo Vision and Touch Probe System, OGP vision System, digital microscopes, and other) Proficiency with engineering software tools for CAD (SolidWorks preferred), engineering analysis, and statistical analysis (e.g. Minitab) Proficiency with Microsoft Office Products Proficiency with basic statistical analysis (normality, standard deviation, variance, and comparison of data groups) including Gage R&R and test method validations Proficiency in inspection equipment and fixture design, development, and implementation Previous direct involvement in medical device industry or a regulated industry. Ability to run self-directed projects, maintain timelines, transfer technology, and execute projects in an R&D and GMP manufacturing environment Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things Strong interpersonal and teamwork skills Demonstrated written and verbal communication skills Proficient with geometric dimensioning and tolerancing and the ability to read mechanical drawings is a plus