Microbiology Quality & Sterility Assurance (MQSA), Scientist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Quality Job Sub Function: R&D/Scientific Quality Job Category: Professional All Job Posting Locations: Palm Beach Gardens, Florida, United States of America, Raynham, Massachusetts, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America Job Description: Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. DePuy Synthes, is recruiting for a Microbiology Quality & Sterility Assurance (MQSA), Scientist , located in West Chester, PA; Palm Beach Gardens, FL; Warsaw IN or Raynham, MA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The MQSA Scientist will serve as a technical leader in microbiological quality, sterilization, and reprocessing, partnering across product development and manufacturing teams to support safe, effective, and compliant medical devices. As a site subject matter expert, this individual will apply technical knowledge and scientific expertise to strengthen microbiological controls, advance sterilization strategies, and help ensure the highest standards of product quality. This role offers the opportunity to contribute directly to patient safety while collaborating with a talented team of scientists and engineers.

Works with Product Development Teams to ensure the microbiological quality requirements are established and met based upon the customer and regulatory needs. Develops radiation sterilization validations or product adoptions of new products. Develops/validates reusable medical device reprocessing instructions (i.e., cleaning, disinfection and/or sterilization) or adopts products into existing health care facility clinical processing instructions. Coordinates the requalification activities needed to ensure a compliant Ethylene Oxide (EO) sterilization program. Investigation of non-conformances, and implementation of corrective actions, and recommend disposition of product. Preparation and evaluation of trending data. Increases awareness of out of specification (OOS) results. Preparation and routing of documents for the change request/change order