QA Engineer 2

Summary: As a member of the Quality Engineering team, this engineer will liaison closely with Receiving Inspection, R&D, Supplier Quality and Operations Engineering to ensure open and timely communication of pipeline project deliverables including but not limited to material specifications, drawings, requirements, fixture design and development, Gage Repeatability & Reproducibility Studies, First Article Inspections, inspection procedures, inspection methods, and sampling plans. Essential Duties and Responsibilities: * 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 Required Qualifications: * 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 AI in Hiring Notice: We may use AI supported tools to help make our hiring process more efficient, consistent, and accessible for candidates around the world. All hiring decisions are made by people.