Quality Engineer - Advanced Wound Care

Medline; Northfield Township (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a quality professional to independently set basic quality standards for in-process and lead methods for testing, sampling and training.

You will evaluate production processes, propose improvements and manage vendor qualification, DMRs, product specs, and design control files.The role requires collaboration with Regulatory Groups and Suppliers for 510K submissions, CAPA leadership, and ensuring compliance with 21 CFR 820 and ISO13485.

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience with design control, CAPA, and regulatory standards (21 CFR 820, ISO13485).
• Strong MS Office and Excel skills; ability to work with cross-functional teams.

Responsibilities

• Develop and implement methods for process control, validation, testing and inspection.
• Design experiments and apply SPC to analyze data and drive improvements.
• Lead supplier quality activities, CAPA/SCAR and supplier qualifications.
• Prepare and maintain Device Master Records, 510K submissions, and design documents.
• Coordinate product testing with labs and ensure compliance with regulations.

Skills

Time management

Problem solving

Attention to detail

Analytical thinking

MS Office proficiency

Education

Bachelor’s degree in Engineering/Science/Math or related field

Tools

MS Office Suite

Microsoft Excel

Job description

Job Summary

Under broad supervision, responsible for independently setting basic quality standards for both in-process 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.

Job Summary

Under broad supervision, responsible for independently setting basic quality standards for both in-process 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.

Job Description

MAJOR RESPONSIBILITIES:

• 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. Applies 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.
• 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.
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• Responsible for building 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).

Education

• Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.

Work Experience

• At least 2 years of experience in the Quality or Engineering.

Knowledge / Skills / Abilities

• 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 problem solving, overcoming obstacles, and reaching a positive and successful solution through mathematical or systematic operations.
• Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook ).
• Intermediate Skill Level in Microsoft Excel (for example: conditional formatting, tables, formulas, charting)
• Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).
• Position requires up to 15% travel.

Preferred Job Requirements

• At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The Anticipated Salary Range For This Position

$79,000.00 - $119,000.00 Annual

The 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.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp. For a more comprehensive list of our benefits please click here.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

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.