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Engineer Quality

Medline · Chicago, IL

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Level
Engineer
Team
Quality
Base pay
$79k–$119k
Degree
Required
Experience asked
2+ years
Industry
Medical devices
Posted
30+ days ago

The role in 30 seconds

An engineer-level quality role at Medline (medical devices) in Chicago, IL.

They ask for
2+ years · degree required
Tools it names
SPC, CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ), Supplier quality
Base pay
$79k–$119k

Read from the posting. The full description is below.

How this role compares

Against 40 other live quality postings in Illinois.

Base pay
About 10% below similar roles

Typical $96k–$125k, from 27 postings that list pay.

Experience asked
Less than usual (2+ vs 3+)

Similar roles usually ask 3+ years.

Skills these teams ask for most

  • ✓ Validation (IQ/OQ/PQ) 49%
  • Root cause 46%
  • ✓ Supplier quality 44%
  • ✓ SPC 39%
  • ✓ Team leadership 39%
  • FMEA 34%

✓ = this posting asks for it too. % = share of similar postings that mention it.

It asks for 2+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone on the team first.

At a glance

Pulled from the posting text. If it's not listed here, the posting didn't say.

How to get in at this plant

Five moves over a week or two. The first one takes ten minutes.

  1. 1

    Pick 2–3 people on the Quality team at Medline

    We found 3 people at this company and state: 3 leaders. Engineers who joined in the last year or two reply the most. See them ↓

  2. 2

    Send a short, curious note

    One real question about their work. No favors yet. Each person gets a different note, written for this role.

    Write to Louis → (free)
  3. 3

    Turn a reply into a short call

    Questions worth asking about this team:

    • What does a normal week look like on your team?
    • Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
    • How much of the job is customer complaints versus prevention?
    • How did you land the job? What stood out in your interviews?
  4. 4

    Apply with someone vouching for you

    If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.

  5. 5

    Bring proof to the interview

    One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.

This plant: Medline in Chicago

7 other open roles at this site · 3 people we found on the quality team.

All 8 roles at Medline →
Full description from MedlineAs posted on their careers site.Show

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

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).

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.

Education

  • ✓None

Work Experience

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

Certification / Licensure

  • •None

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

Certification / Licensure

  • •None

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.

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