Medline Industries, LP
Manufacturing Quality Engineer - Eagan, MN
Medline Industries, LP, Eagan, Minnesota, United States
Manufacturing Quality Engineer - Eagan, MN
Under broad supervision, responsible for independently setting basic quality standards for in-process and product testing, leading efforts to develop methods for testing, sampling, and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain Device Master Records (DMR), product specifications, design control files, and CE technical files.
Responsibilities
Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure optimal product quality.
Design experiments to understand sources of variation affecting products and processes. Apply 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 on defective products to determine trends and lead corrective actions using concepts of probability and statistical quality control.
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 file creation.
Build appropriate product documentation (e.g., Device Master Records) in compliance with applicable regulations. Work with regulatory groups and suppliers to produce 510(k) submissions and related letters.
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 records.
Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
Education
Typically requires a Bachelor’s degree in Engineering, Science, Mathematics, or another related technical field.
Work Experience
At least 2 years of experience in quality or engineering.
Knowledge / Skills
Experience developing ways of accomplishing goals with little or no supervision and determining when to elevate issues.
Ability to use time‑management skills to prioritize, organize, and track details to meet deadlines across multiple projects.
Strong problem‑solving skills and ability to overcome obstacles through systematic approaches.
Proficient with MS Office Suite (Word, Excel, PowerPoint, Outlook); intermediate Excel skills (conditional formatting, tables, formulas, charting).
Working knowledge of government and industry quality assurance codes and standards (e.g., 21 CFR 820, ISO 13485).
Position requires up to 15 % travel.
Preferred Requirements
At least 2 years of industry experience in medical devices, drugs, or related fields directly relevant to the role.
Compensation Annual salary range: $72,280.00 – $105,040.00. Actual salary will vary based on location, education, experience, skills, and abilities. Position is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Benefits Benefit package includes health insurance, life and disability insurance, 401(k) contributions, paid time off, and more for employees working 30 or more hours per week on average. Employees working less than 30 hours receive 401(k) contributions and access to Employee Assistance Program, Employee Resource Groups, and Employee Service Corp. Additional benefits details available on Medline’s benefits page.
Equal Opportunity Medline Industries, LP is an equal opportunity employer. We evaluate 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. We are dedicated to creating a workplace where everyone feels they belong and can grow their career. We seek diversity in all forms, act inclusively, and ensure people have tools and resources to perform at their best.
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Responsibilities
Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection to ensure optimal product quality.
Design experiments to understand sources of variation affecting products and processes. Apply 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 on defective products to determine trends and lead corrective actions using concepts of probability and statistical quality control.
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 file creation.
Build appropriate product documentation (e.g., Device Master Records) in compliance with applicable regulations. Work with regulatory groups and suppliers to produce 510(k) submissions and related letters.
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 records.
Lead investigations of product and process non-conformances and out-of-specification results and develop effective corrective and preventive actions (CAPA).
Education
Typically requires a Bachelor’s degree in Engineering, Science, Mathematics, or another related technical field.
Work Experience
At least 2 years of experience in quality or engineering.
Knowledge / Skills
Experience developing ways of accomplishing goals with little or no supervision and determining when to elevate issues.
Ability to use time‑management skills to prioritize, organize, and track details to meet deadlines across multiple projects.
Strong problem‑solving skills and ability to overcome obstacles through systematic approaches.
Proficient with MS Office Suite (Word, Excel, PowerPoint, Outlook); intermediate Excel skills (conditional formatting, tables, formulas, charting).
Working knowledge of government and industry quality assurance codes and standards (e.g., 21 CFR 820, ISO 13485).
Position requires up to 15 % travel.
Preferred Requirements
At least 2 years of industry experience in medical devices, drugs, or related fields directly relevant to the role.
Compensation Annual salary range: $72,280.00 – $105,040.00. Actual salary will vary based on location, education, experience, skills, and abilities. Position is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.
Benefits Benefit package includes health insurance, life and disability insurance, 401(k) contributions, paid time off, and more for employees working 30 or more hours per week on average. Employees working less than 30 hours receive 401(k) contributions and access to Employee Assistance Program, Employee Resource Groups, and Employee Service Corp. Additional benefits details available on Medline’s benefits page.
Equal Opportunity Medline Industries, LP is an equal opportunity employer. We evaluate 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. We are dedicated to creating a workplace where everyone feels they belong and can grow their career. We seek diversity in all forms, act inclusively, and ensure people have tools and resources to perform at their best.
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