Quality Engineer - Advanced Wound Care

Job Summary

Under broad supervision, responsible for independently setting basic quality standards for in‑process operations while leading efforts to develop methods for testing, sampling and training. Evaluate production process, recommend improvements, qualify and conduct vendor management, generate and maintain DMRs, 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.
• Design experiments to understand sources of variation affecting products and processes; apply SPC methods for data analysis.
• 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 probability and statistical quality control concepts 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 510(k) submissions and related correspondence.
• Coordinate product testing with internal and external laboratories.
• Ensure compliance with domestic and international regulations associated with product lines and processes.
• Perform quality reviews of design documentation for compliance with stated requirements.
• Lead investigations of product and process nonconformances and out‑of‑specification results and develop effective CAPA.

• Bachelor’s degree in Engineering, Science, Math, or related technical field.
• At least 2 years of experience in quality or engineering.
• Experience developing ways of accomplishing goals with little or no supervision and knowing when to elevate issues.
• Strong time‑management skills; ability to prioritize, organize, and track details across multiple projects.
• Analytical problem‑solving abilities using mathematical or systematic operations.
• Experience with MS Office Suite (Word, Excel, PowerPoint, Outlook); intermediate skill level in 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.

Up to 15% travel.

Salary range: $79,000.00 – $ annually; bonus or incentive eligible. Compensation determined by location, education, experience, skills, and abilities.

• Health insurance, life and disability insurance.
• 401(k) contributions.
• Paid time off.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.

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.