Spec Quality

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

Job summary

Medline Industries, LP is seeking a Spec Quality Project Management role focusing on quality system subsections such as device master records and customer complaints. You will build and maintain quality documentation and ensure procedures meet specifications.

The role requires at least 2 years in quality, a bachelor’s in a related field, and ability to collaborate across internal and external teams while following FDA/ISO standards and traveling up to 10% as needed.

Qualifications

• Bachelor's degree in Engineering, Science, Math or related field.
• Minimum 2 years ofQuality experience.
• Experience developing quality documentation and processes.

Responsibilities

• Assist in developing and implementing processes, reports and procedures within specialization.
• Collaborate with internal/external groups to ensure FDA/ISO compliance.
• Facilitate meetings with global units to manage project requirements and deadlines.
• Review documentation for completeness and accuracy to meet specifications.
• Make recommendations based on analysis to improve quality and customer experience.

Skills

Time management

MS Office

Excel

Documentation

Quality assurance

FDA ISO knowledge

Collaboration

Travel readiness

Education

Bachelor's degree in Engineering/Science/Math

Job description

Spec Quality (Project Management)

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.

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.

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.

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.