Spec QA DMR

Job description

Job Summary Job Description Component Sourcing Form Quality review: Secure full reviews and signatures from RA, Sterilization, QA and other relevant functions for all required sections Complete GDP corrections accurately Review content of all forms within packet for accuracy/completeness Review to check all materials of construction for the component are listed Fill out the PS-00023-F-00009 “Component Sourcing Quality review” section: Medline-branded items: Evaluate DMRCs against chemical, physical, sterilization, therapeutic/functional and toxicological criteria for post-EO exposure testing Non-Medline-branded items: Assess components via equivalent Medline testing standards No available EO exposure test data: Adopt piggyback testing, place components into NS kits for hold testing, or submit formal justification Review Reliance quality records covering sterilization, residuals, performance, stability, etc. for target or representative components, referencing the Component Category Matrix (PS-00023-A-00016) Assign dedicated Assign QW codes for sterilization Collect and review Device Master Record (DMR) documents for Medline products subject to the regulatory requirements and project development plan. Other tasks assigned by manager or divisional QA. 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 a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions 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 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.