Quality Engineering S

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 DMR’s, product specifications, design control files, and CE technical files. Support Quality process related activities, analyzes problems related to quality/regulatory information, and provides systems, engineering and technical support in solving these problems. Identify opportunities to improve quality systems and develop strategies which support the success of the business.
Review and determine the application of various system regulations. Identify risk and compliance opportunities.
Collaborate with cross-functional teams to deploy quality processes and systems. 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.
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. Use concepts of probability and statistical quality control to guide decisions.
Provide Quality expertise in Product Development, Design Control activities, Risk Management, and Audit activities.
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.
Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.

Work Experience:
~ At least 2 years of experience in the Quality or Engineering.

Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation of issues is necessary.
Experience using time management skills to prioritize, organize, and track details in order to meet deadlines of multiple projects.
Experience problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting)
Working knowledge of government and industry quality assurance codes and standards (e.g. Position requires up to 15% travel.
At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. xrczosw Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.