at Medline Industries, Inc. in Northfield, Illinois, United States
Job Description
Job Summary
Job Description
Under broad supervision, responsible for independently setting basic quality standards for both in-process while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMRs, product specifications, design control files, and CE technical files.
MAJOR RESPONSIBILITIES:
- Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure that products are ideal and functional.
- Design experiments to understand sources of variation affecting products and processes. Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
- Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Generate and analyze reports and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
- Direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Lead supplier qualifications.
- Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files.
- Responsible for building appropriate product documentation (e.g. Device Master Records) in compliance with applicable regulations. Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc., as required.
- Coordinate product testing with internal and external laboratories as required.
- Ensure compliance with domestic and international regulations associated with product lines and processes. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records.
- Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
Qualifications - External
Education
- Typically requires a Bachelors degree in Engineering, Science, Math or other related technical field.
Work Experience
- At least 2 years of experience in the Quality or Engineering.
Knowledge / Skills / Abilities
- Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
