Spec QA

Medline; Chicago (IL); Sur place; USD 67 000 - 101 000; Plein temps

Avantages offerts par ce poste

Health insurance

Life and disability

401(k) contributions

Paid time off

Continuing education

Résumé du poste

Medline is seeking a Quality Assurance professional in Illinois to specialize in areas of the Quality Management System such as device master records, customer complaints, and recalls. Responsibilities include documenting and maintaining quality processes, analyzing specifications, tolerances, and testing reports, and supporting ERP data analysis.

The role requires a Bachelor's degree in Engineering/Science/Math or related field and at least 2 years in quality, with strong MS Office and

Qualifications

• Bachelor’s degree in Engineering, Science, Math or related field is required.
• At least 2 years of experience in Quality.
• Strong MS Office skills and ability to analyze documentation.
• Working knowledge of government and industry quality assurance standards (e.g. 21 CFR 820, ISO 13485).

Responsabilités

• Assist in developing and implementing processes, reports, data analysis and procedures within the defined area of specialization.
• Collaborate with internal and external groups to ensure compliance with FDA, ISO and internal requirements.
• Facilitate meetings with global units, sales, marketing, and branch personnel to manage project requirements and deadlines.
• Track and report progress to management.
• Review related documentation for completeness and accuracy to meet specifications.
• Make recommendations based on documentation and analysis to improve quality standards and customer experience.

Connaissances

Quality systems

Time management

MS Office

Documentation analysis

FDA/ISO knowledge

Problem solving

Formation

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

Outils

MS Office Suite

ERP system

Description du poste

Job Summary

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

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.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We stride to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.

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. If you’re a self-starter, eager to grow your career within a high-performing environment, this is the place for you.

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, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories.

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