Risk Management Engineer

Job description

Job Summary 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. Job Description 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. 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: $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. 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.