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
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.
Required Qualifications:
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 Qualifications:
Education Masters of Science - Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field.
Certification / Licensure Six Sigma certification.
Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.
Every day, we're focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what's right to delivering business results, together, we're better. Explore our Diversity, Equity and Inclusion page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.