Spec QA

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

Job summary

Medline Industries, LP seeks a Quality Specialist focused on a subsection of our Quality Management System such as device master records, customer complaints, product holds, recalls, or incoming quality. You will help build and maintain quality documentation and processes including specifications, tolerances, drawings, inspection criteria, testing reports, and ERP data analysis.

You will collaborate with cross-functional teams to ensure FDA/ISO compliance, track progress, review documentation

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field.
• At least 2 years of experience in Quality.
• Proficient in MS Office with Excel (intermediate).
• Knowledge of 21 CFR 820 and ISO 13485.

Responsibilities

• Assist in developing and implementing processes, reports, data analysis and procedures within the defined area of specialization.
• Collaborate with multiple groups to ensure FDA/ISO compliance and internal requirements.
• Facilitate meetings with global units to manage project requirements and deadlines.
• Track and report progress to management and ensure documentation completeness and accuracy.
• Review related documentation and analyses to certify specifications are met and suggest improvements.

Skills

Time management

MS Office

Excel

Quality assurance

Education

Bachelor's degree in Engineering, Science, Math or related field

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.
• 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 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.

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time.

To learn more about how Medline makes healthcare run better, visit www.medline.com.