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

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