Medline Industries, LP
Quality Engineer - Personal Care
Northfield, IL | $113K - $150K
Qualifications
- Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files
- This position will require the successful candidate to provide proof that they are fully vaccinated by their start date
- Typically requires a Bachelor's degree in Engineering, Science, Math or other related technical field
- 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. 21 CFR 820, ISO13485)
- Position requires up to 15% travel
Responsibilities
- 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
- 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
- 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)
- 10,001+ employees
- Logistics, Biotechnology, Manufacturing, Pharmaceuticals, Medical Devices, Healthcare Services, Consumer Goods, Healthcare, Wholesale Trade, Medical Equipment and Supplies
- Privately Held
- Northfield, IL
- Company Specialties:
Manufacturing and distribution of medical supplies, Medical Devices, and Supply Chain
Company information
Medline is a healthcare company–a manufacturer, distributor and so much more, doing business in more than 125 countries and territories around the world. We provide the quality medical products and solutions our customers need to deliver their best care to every person in every care setting. Together, we free up the clinical and supply chain resources required to improve the overall operating performance of healthcare. In a complex healthcare world, Medline strives to help our customers achieve both clinical and financial success. We do that through a personalized approach to listen and better understand our customers’ needs in an environment that tirelessly demands lower costs and better outcomes. Our responsiveness and commitment to making healthcare run better is evident in our actions every day. This is who we are. This is why customers choose us as their trusted, integrated business partner.
