Risk Management Engineer

Medline; Illinois; On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline is seeking a Risk Management specialist in Illinois to monitor and enhance risk controls for medical devices and OTC drugs. Candidates should have a Bachelor’s degree in a relevant field and at least 2 years of QA/QE experience, with a strong foundation in data analysis and project management. The role offers a competitive salary range from $79,000 to $119,000 annually, with bonus eligibility. Medline promotes an inclusive workplace culture and offers health insurance and retirement benefits.

Qualifications

• At least 2 years of QA/QE experience in a cGMP Device environment.
• Experience with Data visualization tools/business intelligence tools.
• Strong ability to manage multiple priorities and work independently.

Responsibilities

• Analyze and normalize data to gauge risk management health.
• Collaborate with R&D and manufacturing to implement risk controls.
• Develop timelines for projects and update management on progress.

Skills

Risk management expertise

Data analysis

Project management

Communication skills

Education

Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics

Masters of Science in related field

Tools

Tableau

Power BI

Qlik

Job description

Overview

Job Summary Key contributor within the organization that monitors, maintains, and enhances risk controls by analyzing quality data and major quality events to ensure Medline is properly controlling risks on a global level for medical devices, cosmetics, and OTC drugs. Responsible for managing an automated risk-based trending system that will help the organization foresee risks as well as objectively proving that risk controls are effective. Provide expertise to the organization including education, technical support, issue resolution, and integration of new or enhanced risk controls to be compliant with EU MDR along with satisfying FDA, ISO 13485, and ISO 14971 risk management related processes throughout the product life cycle. Collaborate with Medline’s R&D team during design and development, manufacturing teams to implement appropriate risk controls, post-market surveillance teams to determine if new risks have arisen, and Regulatory Affairs to support FDA inspections.

Major Responsibilities

• Analyze and normalize multiple streams of data to gauge the health of the risk management system. Work with Subject Matter Experts (SMEs) to create a framework for Risk-based dashboards to be used for real-time decision-making and management reporting. Provide detailed input to stakeholders on how to implement risk controls as well as create and implement controls Identify inefficiencies in Medline’s global quality management system. Take action to address identified inefficiencies. Develop timelines for all projects and ensure that deadlines and goals are being met. Frequently update management and team on progress. Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion.
• MINIMUM JOB REQUIREMENTS Education Bachelor of Science Degree in Biology, Chemistry, Engineering or Statistics-based degree. Work Experience At least 2 years of QA/QE experience in a cGMP Device or environment. Complete device life cycle experience related to design, production, use of a device, and ISO 14971. Experience with Data visualization tools/business intelligence tools such as Tableau, Power BI, or Qlik. Experience leading multiple, complex projects. Knowledge / Skills / Abilities Strong ability to manage multiple priorities. Self-starter attitude. Good oral and writing skills. Ability to work independently and as a team in an efficient manner.
• PREFERRED JOB REQUIREMENTS Education Masters of Science – Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field. Certification / Licensure Six Sigma certification.

Compensation

The Anticipated Salary Range For This Position: $79,000.00 - $119,000.00 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.

Benefits

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 review our benefits page.

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.