Quality Assurance Technician responsible for testing and compliance in medical device manufacturing. Ensuring product standards and collaborating across departments at Terumo Medical Corporation.
Responsibilities
Inspecting, testing and release of Finished Product
Ensure compliance with Terumo Medical Corporation quality system and interface with all departments, including manufacturing, engineering, and planning department for any questions or requests
Follow requirements of applicable national and international regulations
Verify and review Device History Records to ensure compliance per procedures
Use computer systems to maintain traceability and appropriate hold/release status of materials and finished goods
Perform testing of incoming materials to verify materials meet specifications
Provide production Supervisor with assistance of documentation errors/corrections within the DHR process
Support production request for raw material inspection for priority release
Participate in project performance team meetings on behalf of the job unit to provide ideas, methods or processes for unit/company performance improvement
Assist in training of new associates
Requires data analysis such as trending of DHR errors, or raw material inspection time
Submission of change orders as deemed necessary
Perform other job-related duties as assigned
Requirements
Requires a high school diploma
Associate degree or some college classes preferred
Prior quality assurance or manufacturing experience preferred
Basic computer knowledge
Mathematical knowledge, including algebra and utilization of sampling and statistical charts
Critical thinking skills and decision-making ability
Ability to use testing equipment, i.e., calipers, micrometers, microscope, optical comparator, Instron, etc.
Conscious of quality with the ability to recognize deviations from established standards and procedures with a high level of concentration
Ability to make product acceptability choices based upon quality criteria, testing results and product requirements.
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