New · posted Nov 4
Medline · Medical Devices
Engineer Quality
- Chicago, IL
- On-site
- Full-time
- Associate & Specialist
The role
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.
What you need
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
Work Experience
- At least 2 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
Knowledge / Skills / Abilities
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.
What you'll do
- 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).
Pay and benefits
$79,000 – $119,000 a year
Employer providedHealth insurance
Life and disability insurance
401(k) contributions
Paid time off
Bonus/incentive eligible
Continuing education & training
Where you'll work
Chicago, ILOn-siteOpen in Maps (opens in a new tab)
More jobs in Chicago, ILEqual opportunity, accessibility and legal noticesMedline's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 4, 2026
Salary intelligence
How the pay compares
This role's midpoint is 18% above the US median for Quality Engineering roles at this level.
This roleEmployer provided
Associate & Specialist roles in Illinois16 roles publishing pay
Associate & Specialist roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $79,000 | — | $119,000 |
| Illinois (middle half) | $84,000 | $99,000 | $99,000 |
| All US (middle half) | $73,000 | $84,000 | $99,000 |
This role: Medline's own published range. Comparisons: the base pay employers published on open Quality Engineering roles at the same level on Regulatory Jobs, November 4, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Engineering
The general path across 211 open Quality Engineering roles on Regulatory Jobs, with the titles they carry most. Not Medline's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership5
- GMP and compliance4
- Lab testing and methods4
- Documentation and SOPs4
- Quality systems and risk4
- Investigations and CAPA2
- Data and digital systems2
- Validation and qualification1
- Regulatory submissions1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Engineering work in medical devices, led by the three this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485Named in the posting
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- FDAFDA 510(k)(official source, opens in a new tab)Premarket notification: showing substantial equivalence to a legally marketed deviceNamed in the posting
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
Company hiring pulse
Medline on Regulatory Jobs
- 59
- Open roles
- 43
- Distinct roles
- 19
- Locations
By discipline
- Quality51 86%
- Regulatory7 12%
- Clinical1 2%
By level
- Associate & Specialist39 66%
- Senior & Principal15 25%
- Director2 3%
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Engineer Quality at Medline
Open until filled. $79K–$119K a year, employer provided.