Spec QA
Medline Industries, LP
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 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
Requirements
- Bachelor’s degree in Engineering, Science, Math or other related field
- At least 2 years of experience in Quality
- Experience developing ways of accomplishing goals with little or no supervision
- Experience using time management skills to prioritize, organize, and track details
- Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook), with 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
Benefits
- Health Insurance
- Life Insurance
- Disability Insurance
- 401(k) Contributions
- Paid Time Off
- Employee Assistance Program
- Employee Resource Groups
- Employee Service Corp
Company overview
Medline Industries, LP is the largest privately held manufacturer and distributor of medical-surgical products and supply chain solutions in the United States. Founded in 1966 and headquartered in Northfield, Illinois, the company serves all points of care including hospitals, extended care facilities, surgery centers, physician offices, home care agencies, and retailers. With over 550,000 medical products and clinical solutions, Medline operates in more than 125 countries and territories worldwide. The company employs approximately 35,000-43,000 people globally and generates annual revenues exceeding $21 billion. Medline's comprehensive portfolio includes medical devices, surgical supplies, wound care products, protective apparel, durable medical equipment, and sterilization solutions. The company combines manufacturing expertise with extensive distribution capabilities through its network of over 50 distribution centers across North America, providing integrated supply chain solutions that help healthcare organizations improve clinical, financial, and operational outcomes.