Microbiology Quality & Sterility Assurance (MQSA), Scientist

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Quality

R&D/Scientific Quality

Professional

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

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
.

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

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 processes.
• Experience writing standard operating procedures, validation protocols, and validation reports.
• Compliance with GMP/GDP requirements and guidelines.

• Bachelors or equivalent university degree in Microbiology, Biomedical…