Ethicon, LLC, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Finished Goods Release QA Coordinator to be located in San Lorenzo, PR. Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the worlds most pressing health care issues and improve and save more lives. Through Ethicons surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer. As the Finished Goods Release QA Coordinator, you will: Review and complete transactions such as, but not limited to, batch records, Sterilization Certificates of Processing and appropriate records retention in Manufacturing and Quality Systems to release Finished Goods products. Notify about any non-conformance related to the QA inspection and test methodologies. Generate the Non-Conformance Report (NC) to the impacted Department. Evaluate the precision and accuracy of products, production equipment, and/or testing equipment. Use the LIMS and JDE software to document the inspection results and disposition to product prior to release. Collect or oversee the collection of Finished Goods and Retain samples at the sterilization site when needed for testing and for evaluation. Perform data analysis and recommends disposition of material. Segregate Finished Goods samples and Retain Samples according to the requirements. Generate Certificate of Analysis (COA) as per Client’s and other Plants Requests. Support Sterilization Diversion activities. Handle efforts among Sterilization Plant and Ethicon. Maintain accurate and precise documentation of their daily and weekly activity sheets. Assist the Engineering and QA Departments in validation activities. Perform other duties as required by Supervisor or Quality Operations Leader. Train new Finished Goods QA Technician and Finished Goods Release Quality Coordinator applicable job functions. Qualifications A minimum of an Associate Degree from an accredited institution, preferably in a technical or science field, with 1-3 years of experience in quality assurance; or a minimum of 8 years of proven experience in quality assurance is required. Previous experience in Finish Goods is preferred. Experience in Medical Devices, Pharma or Consumer environment is preferred. Knowledge of QSR’s and ISO Standards is required. Proficiency with Microsoft Office tools (Word, Excel, PowerPoint) is required. Knowledge in LIMS, EtQ and JDE is preferred. Bilingual (Spanish & English) is required. The position requires availability to work 3rd shift and have flexibility to work overtime, holidays, alternate, extended shifts and/or irregular hours including weekends, per operational needs. This position requires up to ten percent (10%) of travel. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
