Quality Engineer

Netrolynx AI; United States; On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Continuing education opportunities

Job summary

Medline Industries, LP in the United States seeks a quality professional to ensure products and manufacturing meet safety, performance, and reliability standards. Under broad supervision, you will establish basic in-process quality standards and lead testing, sampling, and training methods.

You will evaluate production processes, support product development and design control, and help maintain compliance with applicable domestic and international regulations. Travel of up to 15% may be required.

Qualifications

• Bachelor’s degree in engineering, science, mathematics, or related technical field.
• At least two years of experience in quality or engineering.
• Knowledge of 21 CFR 820 and ISO 13485.
• Structured problem-solving skills and ability to manage multiple projects.

Responsibilities

• Develop and implement methods for process control, validation, and inspection.
• Design experiments and apply SPC to analyze data and inform decisions.
• Plan and conduct product testing to maintain quality and reduce defects.
• Review quality data and lead corrective actions.
• Investigate non-conformances and develop CAPA.
• Collaborate with suppliers on quality concerns and SCAR.
• Provide quality expertise for product development and design control.
• Create and maintain DMRs, specifications, and technical documentation.
• Coordinate testing with laboratories and assist with regulatory submissions.

Skills

Excel

Word

PowerPoint

Outlook

Analytical thinking

Prioritization

Education

Bachelor’s degree in engineering/science/math

Job description

About The Company

Medline Industries, LP is a growing global healthcare organization focused on supporting healthcare providers and improving care through medical products and services. The company offers employees opportunities to contribute to meaningful work, develop their skills, and grow their careers within a worldwide organization. Medline is committed to creating an inclusive workplace where people have the resources and support to do their best work.

About The Company

Medline Industries, LP is a growing global healthcare organization focused on supporting healthcare providers and improving care through medical products and services. The company offers employees opportunities to contribute to meaningful work, develop their skills, and grow their careers within a worldwide organization. Medline is committed to creating an inclusive workplace where people have the resources and support to do their best work.

About The Role

Medline is seeking a quality professional to help ensure that products and manufacturing processes meet established standards for safety, performance, and reliability. Working under broad supervision, you will independently establish basic in-process quality standards and lead efforts to develop testing, sampling, and training methods. You will evaluate production processes, recommend improvements, support product development and design control, and help maintain compliance with applicable domestic and international regulations. This position requires sound judgment, analytical thinking, and the ability to manage several priorities with limited supervision. Travel of up to 15% may be required.

Qualifications

A bachelor’s degree in engineering, science, mathematics, or a related technical field is typically required. Candidates should have at least two years of experience in quality or engineering; experience in medical devices, pharmaceuticals, or a related industry is preferred. A certification or professional license is not required. The successful candidate will have working knowledge of government and industry quality requirements, such as 21 CFR 820 and ISO 13485, and experience applying structured problem‑solving methods. Intermediate Microsoft Excel skills are expected, including the use of formulas, tables, conditional formatting, and charts. Proficiency with Microsoft Word, PowerPoint, and Outlook is also important. Candidates should be organized, able to prioritize and track multiple projects, meet deadlines, and recognize when issues should be escalated.

Responsibilities

• Develop and implement methods for process control, validation, improvement, testing, and inspection to support product quality and functionality.
• Design experiments to identify sources of variation, apply statistical process control (SPC) to analyze data and assess process changes, and use statistical quality principles to inform decisions.
• Plan and conduct product testing and analysis to maintain quality levels and reduce defects and failure rates.
• Review quality data, reports, and defective products to identify trends and lead corrective actions.
• Investigate product and process non‑conformances and out‑of‑specification results, determine root causes, and develop effective corrective and preventive actions (CAPA).
• Collaborate with suppliers on quality concerns, follow up on CAPA and supplier corrective action requests (SCAR), lead supplier qualifications, and contribute to supplier improvement programs.
• Provide quality expertise for product development, design control, risk management, and CE technical files.
• Create and maintain required product documentation, including Device Master Records (DMRs), product specifications, design control files, and technical documentation.
• Review design records, supplier quality documents, and company quality records for compliance with stated requirements.
• Coordinate product testing with internal and external laboratories, and partner with Regulatory teams and suppliers on 510(k) submissions, letters to file, and related documentation as needed.

Benefits

• The anticipated annual salary range is $79,000 to $119,000. Actual compensation will depend on factors including location, education, experience, skills, and abilities. This position may be eligible for bonus and/or incentive compensation. Medline will comply with applicable minimum wage and salary requirements.
• Employees working an average of 30 or more hours per week are eligible for benefits that include health insurance, life and disability coverage, 401(k) contributions, and paid time off.
• Employees working fewer than 30 hours per week may have access to 401(k) contributions, paid time off, the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corp.
• Medline also offers continuing education and training opportunities.

Equal Opportunity

Medline Industries, LP is an equal opportunity employer. We value diversity, foster inclusion, and aim to create a workplace where everyone can belong and grow. Qualified applicants are considered 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 law.