Senior Quality Engineer - NAMIC

Job Summary

Under minimal 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 complex experiments to understand sources of variation affecting products and processes; apply 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 effective corrective actions are implemented (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.
• Responsible for building appropriate product documentation (e.g., Device Master Records) in compliance with applicable regulations; work with regulatory groups and suppliers to produce 510(k) 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 and vendor quality documents.
• Lead investigations of product and process non‑conformances and out‑of‑specification results, develop effective corrective and preventive actions (CAPA).
• May train and coach team members and Medline employees on appropriate processes and best practices.
• Act as quality lead in the absence of quality management.

• Bachelor’s degree in Engineering, Science, Math or another related technical field.
• At least 4 years of experience in quality or engineering.
• Experience applying knowledge of government and industry quality assurance codes and standards (21 CFR 820, ISO
  13485, 21 CFR 210 and 211, MDD/MDR, ANSI/AAMI/ISO sterilization standards).
• Experience developing ways of accomplishing goals with little or no supervision, determining when escalation is necessary.
• Experience using time‑management skills to prioritize, organize, and track details in order to meet deadlines across multiple projects.
• Experience problem‑solving, overcoming obstacles, and reaching successful solutions through systematic operations.
• Experience leading a team to accomplish cross‑functional goals.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
• Advanced skill level in Microsoft Excel (pivot tables, conditional formatting, tables, formulas, charting).
• Position requires up to 15% travel.

• At least 5 years of industry experience in medical devices, drugs, or related fields.
• Knowledge of advanced Six Sigma/Lean concepts.

$ – $ annual. Salary will vary based on location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

The benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, and other benefits for employees working 30 or more hours per week. For roles with less than 30 hours per week, benefits include 401(k) contributions, paid time off, access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp. For a more comprehensive list of benefits, view the complete benefits guide.

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.