Full-Time

Sr. Quality Engineer

Urology

Posted on 1/15/2025

Medline

Medline

5,001-10,000 employees

Provider of medical supplies and healthcare solutions

Industrial & Manufacturing
Healthcare

Compensation Overview

$96.2k - $144.6kAnnually

+ Bonus + Incentive

Senior

Northbrook, IL, USA + 1 more

More locations: Chicago, IL, USA

Category
QA & Testing
Manual Testing
Quality Assurance
Required Skills
Risk Management
Excel/Numbers/Sheets

You match the following Medline's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • Bachelor’s degree in Engineering, Science, Math or other related technical field.
  • At least 4 years of experience in the Quality or Engineering.
  • Experience applying knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485, 21 CFR 210 and 211, MDD/MDR, and ANSI/AAMI/ISO sterilization standards).
  • Experience developing ways of accomplishing goals with little or no supervision, depending on oneself to complete objectives, and determining when escalation 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 leading a team to accomplish cross-functional goals.
  • Experience using MS Office Suite products (Word, Excel, PowerPoint, and Outlook).
  • Advanced Skill Level in Microsoft Excel (for example: Pivot tables & pivot reporting, conditional formatting, tables, formulas, charting).
  • Position requires up to 15% travel.
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 complex 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 that effective corrective actions are implemented (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).
  • May train and coach team members and Medline employees on appropriate processes and best practices.
  • Act as Quality lead in the absence of Quality Management.
Desired Qualifications
  • At least 5 years of industry experience in Medical Devices, Drugs, and/or fields directly related to the role.
  • Knowledge of advanced Six Sigma/Lean concepts.

Medline supplies medical products and healthcare solutions to hospitals, nursing homes, and home health agencies. Their extensive catalog includes protective gear, wound care items, diabetes care supplies, and home diagnostics, sold directly to healthcare providers. Medline stands out from competitors with its focus on sustainability and investments in domestic supply chain infrastructure. The company's goal is to improve healthcare delivery through reliable products and services.

Company Size

5,001-10,000

Company Stage

Grant

Total Funding

$486.4K

Headquarters

Mundelein, Illinois

Founded

1966

Simplify Jobs

Simplify's Take

What believers are saying

  • Increased demand for home diagnostics aligns with Medline's product offerings.
  • The rise of personalized medicine boosts demand for Medline's specialized supplies.
  • Expansion of outpatient care facilities increases demand for Medline's B2B model.

What critics are saying

  • Market saturation in medical supplies could limit Medline's growth opportunities.
  • Healthcare industry consolidation may reduce potential clients for Medline.
  • Rising raw material costs could squeeze Medline's profit margins.

What makes Medline unique

  • Medline offers a diverse catalog of medical supplies and healthcare solutions.
  • The company has a strong B2B model, directly serving healthcare providers and institutions.
  • Medline is recognized for supply chain excellence and industry leadership.

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Benefits

Health Insurance

Life Insurance

Disability Insurance

401(k) Company Match

Paid Vacation

Paid Sick Leave

Company News

PYMNTS
Jan 12th, 2025
Investment Bankers Banking On An Ipo Turnaround In 2025

Investment bankers are reportedly preparing for a dealmaking uptick in equity capital markets this year. Optimism among Wall Street’s banks is being fueled by a promising stable of initial public offerings (IPOs) by high-profile companies, Reuters reported late Friday (Jan. 10). Among these companies are liquified natural gas producer Venture Global, medical supplier Medline, and cybersecurity firm Sailpoint, the report said, citing sources familiar with the matter

PYMNTS
Jan 5th, 2025
Wall Street Reportedly Prepping Private Equity-Fueled Ipo Revival

Will 2025 bring about a revival in the initial public offering (IPO) market?. As the Financial Times (FT) reported Sunday (Jan. 5), it’s a rebound Wall Street banks are preparing for, as private equity companies turn to the equities markets to offload some of their high-profile holdings. The report noted that a number of private equity-backed firms have already filed IPO paperwork, among them the medical devices company Medline and software maker Genesys

Fierce Healthcare
Dec 19th, 2024
Medical supply firm Medline confidentially files for potential blockbuster IPO in 2025

Medical equipment and supply manufacturer Medline Industries confidentially submitted plans for a proposed initial public offering, potentially setting the stage for a blockbuster public debut next year.

PR Newswire
Dec 9th, 2024
Modern Healthcare Recognizes Medline For Supply Chain Excellence And Industry Leadership

Medline named to Best in Business list; CEO Jim Boyle named to 2024 100 Most Influential People in Healthcare listNORTHFIELD, Ill., Dec. 9, 2024 /PRNewswire/ -- Medline is proud to announce two prestigious accolades from Modern Healthcare. Medline CEO Jim Boyle has been named one of the 100 Most Influential People in Healthcare for 2024, and Medline has been recognized as one of the Best in Business for 2024 in the supply chain category. These honors highlight exceptional leadership and innovation driving the healthcare industry forward

VC News Review
Dec 9th, 2024
Modern Healthcare recognizes Medline for supply chain excellence and industry leadership

Medline CEO Jim Boyle has been named one of the 100 Most Influential People in Healthcare for 2024, and Medline has been recognized as one of the Best in Business for 2024 in the supply chain category.

PR Newswire
Nov 22nd, 2024
Medline Announces Leadership Updates

Current President Chief Operating Officer (COO) to retire in 2025; New Chief Product Officer and new COO named. NORTHFIELD, Ill., Nov. 22, 2024 /PRNewswire/ -- Medline today announced a series of leadership changes, including that Jim Pigott (currently President COO) will retire from the company at the end of 2025. Additionally, Amanda Laabs (currently EVP, Medline Brand) is being promoted to Chief Product Officer, and Steve Miller (currently EVP, Supply Chain) is being promoted to the role of Chief Operating Officer, both effective January 1, 2025. "Jim Pigott has been instrumental to our success as a company, and his leadership has helped Medline accelerate its growth and expand its impact in meaningful ways," said Jim Boyle, CEO of Medline. "We are appreciative of Jim staying on through the transition next year, and we wish him all the best in the next chapter."

Crain's Chicago Business
Nov 22nd, 2024
Medline could raise $5B in a 2025 IPO, report says

Medline could raise $5B in a 2025 IPO, report says.

TipRanks
Nov 22nd, 2024
Medline Industries Could Launch a $5B IPO in 2025

New reports claim that medical supply company Medline Industries is planning for an initial public offering (IPO) as early as Q2 2025.

LiveMint
Nov 21st, 2024
Medical supply firm Medline aims to raise over $5 billion in 2025 IPO, sources say

Medical supply firm Medline aims to raise over $5 billion in 2025 IPO, sources say.

Medline Industries
Nov 19th, 2024
Northern California-based Sutter Health extends Medline prime vendor agreement to Lab and EVS

Northfield, Ill., Nov. 19, 2024 - Medline today announced that it has expanded its medical surgical prime vendor agreement with Northern California-based healthcare network Sutter Health to include lab and environmental services (EVS).

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