Job Description
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.
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