The Quality Engineer provides support to both new product development and continuous improvement initiatives for existing product lines. This person uses statistical analysis, test method development, engineering principals, and awareness of relevant procedural and regulatory requirements to move projects and initiatives to successful completion.
Essential Job Functions:
- Identify applicable quality standards and appropriate test methods for the assessment of product and/or process performance
- Implement Design Control during the launch of new products and significant product design changes
- Review designs, design changes, validation plans, and specification changes and makes recommendations relevant to compliance, risk, and performance
- Track and review corrective and preventive actions (CAPA’s)
- Document non-standard/nonconforming processes or product and then work with other engineers and departments to find a solution and disposition
- Perform experiments, applying accepted design of experiment techniques
- Author and execute test method and process validations
- Develop sampling plans by applying attribute, variable, and sequential sampling methods
- Analyze data by completing hypothesis testing, 2 sample t-tests, and process capability analyses
- Prepare reports by collecting, analyzing, and summarizing data; making recommendations
- Bachelor’s degree in engineering or other technical discipline
- Proven record of test method development, execution of validations, and data-based decision making
- 2-5 years of work experience in a similar role, ex. laboratory testing,documentation of test reports and test protocols, prototyping, or commercialization
- Self-starter and comfortable being a subject matter expert within the company
- Experience in the medical device field a plus
- Analyzing Data/Information
- Reporting Research Results
- Technical Understanding
- Quality Engineering
- Team Leadership
- Promoting Process Improvement
- Developing Standards
- Managing Processes
- Manufacturing Methods and Procedures
- Supports Innovation
- Operations Research
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Therefore, employees assigned may be required to perform additional job tasks required by the manager.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
KORU Medical Systems provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex,sexual orientation, marital status, pregnancy, parental status, national origin, ethnic background, age, disability, political opinion, social status,veteran status, union membership or genetics.
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