Quality Engineer - Diagnostics

Regulatory Jobs; Chicago (IL); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

Life and disability

401(k) contributions

Paid time off

Job summary

Medline Industries, LP seeks a quality professional to set basic quality standards and lead methods for testing, sampling and training. You will evaluate production processes, justify improvements, manage vendors, generate DMRs, product specs and CE technical files.

Responsibilities include applying SPC, designing experiments, CAPA, SCAR, and building documentation to comply with 21 CFR 820/ISO13485. Travel up to 15% may be required, with a competitive benefits package.

Qualifications

• Experience applying SPC to analyze data and guide process changes.
• Experience building device master records and design history files.
• Familiarity with 21 CFR 820 and ISO13485 quality systems.

Responsibilities

• Manage methods for process control, validation, improvement, testing, and inspection.
• Design experiments to understand variation and guide decisions.
• Lead CAPA/SCAR and supplier quality improvement programs.
• Develop and maintain QMS documentation for regulatory submissions.
• Coordinate product testing with internal/external labs and ensure compliance.
• Lead investigations of non-conformances and implement effective corrective actions.

Skills

SPC analysis

Quality Assurance

Vendor management

CAPA

Regulatory knowledge

MS Office

Process control

Education

Bachelor’s degree in Engineering/Science

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 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. 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).

MINIMUM JOB REQUIREMENTS:

Education:

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

Certification / Licensure:

• None

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:

Education:

• None

Certification / Licensure:

• None

Work Experience:

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

Knowledge / Skills / Abilities:

• None

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 pagehere.

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.