Duties and Responsibilities

• Adhere to the Company’s Quality System, including all applicable SOPs in the Training Matrix.
• Supervise and perform testing and inspection activities, including training inspectors or technicians.
• Develop and operate programs for the coordinate measuring machine to support quality lab testing projects.
• Perform lab testing in collaboration with R&D Engineering, Manufacturing Engineering, and the quality lab.
• Develop and document control plans to verify production meets stated requirements.
• Apply statistical methods to determine sample sizes and evaluate risk-based data for protocol and test method development.
• Generate protocols and reports for design verification, interfacing with R&D Engineering to align testing with design inputs.
• Maintain and support inspection records.
• Provide quality and reliability engineering for product development projects per ISO and FDA requirements.
• Review components, products, and processes to optimize inspection methods, sampling plans, and documentation.
• Train employees on quality standards.
• Collaborate with the equipment coordinator to ensure gauge calibration and maintain metrology data.
• Support validation and qualification studies in production.
• Create, modify, and implement internal and external quality systems and procedures.
• Analyze production nonconformance to determine root causes and facilitate corrective/preventative actions.
• Summarize and report nonconformance trends and major causes.
• Plan and document studies for measurement repeatability, reproducibility, and process capabilities.
• Conduct internal and supplier audits as required.
• Utilize inspection, measuring, and testing equipment as necessary.