Quality Engineer – Rehab and Fall Prevention

Overview

Under broad supervision, the Quality Engineer provides cross‑divisional support for remediation efforts, independently setting and upholding quality standards for a portfolio of medical device, commodity, OTC drug, and cosmetic products. Responsibilities include evaluating production processes, recommending improvements, qualifying and conducting vendor management, and generating and maintaining DMRs, product specifications, design control files, and CE technical files.

• Provide quality expertise in product development, design control activities, design history files, CAPA, risk management, and CE technical files.
• 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.
• Lead investigations of product and process non‑conformances and out‑of‑specification results, developing effective corrective and preventive actions (CAPA).
• 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.
• Manage 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 and defective products to determine trends and lead corrective actions. Use concepts of probability and statistical quality control to guide decisions.
• Coordinate product testing with internal and external laboratories as required.
• 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.

• Education:
  
  Typically requires a bachelor’s degree in engineering, science, math or other related technical fields.
• Work Experience:
  
  2+ years of experience in quality or engineering.
• Knowledge/Skills/Abilities:
  • Developing ways of accomplishing goals with little or no supervision and determining when escalation is necessary.
  • Using time‑management skills to prioritize, organize, and track details to meet deadlines on multiple projects.
  • Problem‑solving, overcoming obstacles, and reaching positive solutions through mathematical or systematic operations.
  • Using MS Office Suite products (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).
  • Position requires up to 15% travel.
• Preferred Requirements: 2+ years of industry experience in drugs, cosmetics, and/or fields directly related to the role.

The anticipated salary range for this position is $79,000.00 – $ per annum. Actual salary will vary based on applicant’s 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.

Benefits include health insurance, life and disability insurance, 401(k) contributions, paid time off, employee assistance program, employee resource groups, and employee service corp for employees working at least 30 hours per week. Part‑time employees receive 401(k) contributions, paid time off, and access to the employee assistance program and employee resource groups.

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.