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$79k–$119k/yr
Full-time
bachelor degree
Health Insurance, Life Insurance, Disability Insurance, 401(k) Contributions, Paid Time Off, Employee Assistance Program
Posted 14d ago
~40 hrs/week
Responsibilities
Responsible for setting quality standards, developing testing methods, and managing process validation and improvement. The role involves leading supplier qualifications, maintaining device master records, and ensuring compliance with domestic and international regulations.
Requirements
Requires a Bachelor's degree in Engineering, Science, or Math with at least 2 years of experience in Quality or Engineering. Proficiency in MS Office and knowledge of medical device quality standards like ISO 13485 and 21 CFR 820 are essential.
Full 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).
Education:
Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.
Work Experience:
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:
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.
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care.
Industry
Medical Equipment Manufacturing
Company size
10,001+ employees
Headquarters
Northfield, IL
LinkedIn followers
450,333
Total funding
$6.5B
Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Ill., the company employs more than 45,000 people worldwide and operates in more than 100 countries. To learn more about how Medline makes healthcare run better, visit www.medline.com.
Offices: Three Lakes Drive, Northfield, IL 60093, US · Pune, IN · One Medline Place, Mundelein, IL 60060, US · Nuevo Laredo, MX · Mexicali, MX
Manufacturing and distribution of medical suppliesMedical Devicesand Supply ChainConsumer GoodsHealth CareHospitalityMedicalManufacturing
Based on 3751 listings with disclosed salaries, most manufacturing jobs in Illinois pay between $68k–$155k per year. Individual offers vary with seniority, company size, and specialization.
How many Manufacturing jobs are open in Illinois right now?
There are currently 10,713 open manufacturing positions in Illinois listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Manufacturing roles in Illinois?
Companies currently hiring include Caterpillar Inc., Allergan, RJW Logistics Group, Northrop Grumman, Kraft Heinz, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Manufacturing jobs in Illinois?
Yes — 1016 of the 10713 open manufacturing positions offer remote or hybrid work (238 remote, 778 hybrid).
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