Spec QA

Medline Industries, Inc.; Mundelein (IL); On-site; USD 67,000 - 101,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in Mundelein, IL is seeking a Quality Associate to specialize in a subsection of our Quality Management System, such as device master records, customer complaints, recalls, or product holds. You will help build and maintain quality documentation, specifications, tolerances, drawings, inspection criteria and test reports while ensuring compliance with FDA/ISO standards.

The role emphasizes collaboration with internal and external teams, data analysis, and adherence to

Qualifications

• Experience implementing quality processes and documentation with minimal supervision.
• Strong data analysis, prioritization, and reporting skills.
• Familiarity with FDA/ISO 21 CFR 820 and ISO 13485 standards.

Responsibilities

• Assist in development and implementation of processes, reports, and procedures within area of specialization.
• Collaborate with internal and external groups to maintain compliance with FDA, ISO and internal requirements.
• Facilitate meetings with global units to manage project requirements and deadlines; track progress.
• Review documentation for completeness, accuracy, and conformance to specifications.
• Make recommendations based on analysis to improve quality and customer experience.

Skills

Self-motivation

Time management

MS Office

Analytical thinking

Quality standards knowledge

Travel up to 10%

Education

Bachelor’s degree in Engineering/Science/Math or related field

Tools

MS Excel

ERP systems analysis

Quality management software

Job description

Job Summary

This role specializes in one or two particular subsection(s) of our Quality Management System (e.g. Device Master Records, customer complaint, product hold, recalls, incoming quality). Responsible for basic building and maintaining quality documentation and processes such as product specifications, manufacturing tolerances, engineering drawings, inspection criteria, testing reports, ERP system analysis, customer complaint analysis and validations.

Job Description

MAJOR RESPONSIBILITIES:

• Assist in the development and implementation of processes, reports, data analysis and procedures within the defined area of specialization.
• Collaborate with multiple groups (both internal and external) to solve complex problems and continue to ensure compliance is maintained with FDA, ISO and internal requirements.
• Facilitate meetings with global business units, sales, marketing, branch personnel to manage project requirements and deadlines. Track and report progress periodically to management.
• Review all related documentation and analysis for completeness, accuracy, and assure the product and reports meets all specifications.
• Make recommendations and decisions based off the documentation and analysis that leads to better quality standards and customer experience.

MINIMUM JOB REQUIREMENTS:

Education:

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

Certification / Licensure:

• None

Work Experience:

• At least 2 years of experience in Quality.

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 using MS Office Suite products (Word, Excel, PowerPoint, Outlook ), with an Intermediate skill in Excel.
• Experience in processing all relevant details, understanding and prioritizing their importance, and drawing clear and concise conclusions.
• Working knowledge of government and industry quality assurance standards (e.g. 21 CFR 820, ISO 13485).
• Position requires up to 10% travel

PREFERRED JOB REQUIREMENTS:

Education:

• None

Certification / Licensure:

• None

Work Experience:

• 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.

The anticipated salary range for this position:

$67,000.00 - $101,000.00 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.