Engineers Quality
Job Summary Job Description Medline Industries, LP is seeking an Engineers Quality to join our team in Chicago, IL. Job Description 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. Use concepts of probability and statistical quality control to guide decisions. Design and perform experimental product testing and analysis to maintain quality levels and minimize defects and failure rates. Design experiments to understand sources of variation affecting products and processes. Coordinate product testing with internal and external laboratories as required. Generate and analyze reports and defective products to determine trends and lead corrective actions. Lead supplier qualifications and direct and collaborate with supplier representatives on quality problems, ensure corrective action implementation (CAPA, SCAR), and contribute to supplier quality improvement programs. Provide Quality expertise in Product Development, Design Control activities, Risk Management, and CE Technical Files. Perform quality reviews of design documentation for compliance with stated requirements, including vendor quality documents and company quality records. 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. Ensure compliance with domestic and international regulations associated with product lines and processes. Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA). Telecommuting is permitted, but applicant must work from the worksite location at least 3 days per week. Up to 15% travel required to visit other company sites for various reasons including training, performing investigations, visiting vendor and customer sites. Job Requirements PRIMARY REQUIREMENTS: Bachelor’s degree in Industrial and Systems Engineering, Engineering, Science, Math, or related Technical Fields, and 2 years of relevant work experience. In addition, experience with the following skills is required: (1) Experience with working knowledge of government and industry quality assurance codes and standards including 21 CFR 820 and ISO13485; (2) Experience working on problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations; (3) Experience supporting Medical Device design and manufacturing; (4) Experience supporting Medical Device post market activities including Complaint Investigations, CAPA, SCAR, NCMR, Deviation, and Health Hazard Analysis; and (5) Experience working with domestic and international CMOs and Suppliers. JOB SITE: 222 W. Merchandise Mart Plaza, Suite 1200, Chicago, IL 60654 WORK HOURS: Full Time (8am to 5pm, Monday to Friday) PAY RANGE: $100,706.00 to $119,000.00 per year Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. 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’re dedicated to creating a Medline where everyone feels they belong and can grow their career. 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. Explore our Belonging page here . Medline Industries, LP is an equal opportunity employer. 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.
