Manufacturing Quality Engineer - Mankato, MN

Job Summary

Under broad supervision, responsible for independently setting basic quality standards for in‑process activities 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. 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. 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.
• Build 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).

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 field.

• 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 with problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
• Experience using the MS Office Suite (Word, Excel, PowerPoint, Outlook). Intermediate skill level in Microsoft Excel (conditional formatting, tables, formulas, charting).
• Working knowledge of government and industry quality assurance codes and standards (e.g., 21 CFR 820, ISO 13485).

• At least 2 years of industry experience in medical devices, drugs, or related fields.
• Position requires up to 15% travel.
• Competitive total rewards package with continuing education and training and opportunity for growth within a worldwide organization.
• Salary range: $79,000.00 to $ per year. Bonus or incentive eligible.

Our benefit package includes health insurance, life and disability coverage, 401(k) contributions, paid time off, and an employee assistance program, among others, for employees working at least 30 hours per week on average. For roles with less than 30 hours per week, benefits include 401(k) contributions, paid time off, and access to employee resource groups and service corporations.

Medline Industries, LP 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.