Description
Robotics & Digital Solutions at Auris Health, a member of the Johnson & Johnson Family of Companies, is recruiting for a Staff Scientist Microbiological Quality and Sterility Assurance, Robotics & Digital Solutions (RAD) located in Redwood City, CA, Santa Clara, CA, or Cincinnati, OH!
Robotics & Digital Solutions is part of Johnson and Johnson MedTech, a global leader in medical devices with products and solutions found in almost every operating room around the world. Robotics & Digital Solutions is transforming medical intervention, by combining advancements in medical robotics, instrumentation, navigation and data science. We are building a platform technology capable of expanding the applicability of robotics to a spectrum of medical procedures. This role will support innovations on the platforms that started with Auris Health, see https://www.aurishealth.com.
The Staff Sterilization Scientist MQSA provides technical leadership within the RAD business. This position requires the translation of product Microbiological and Sterility Assurance (MQSA) quality requirements into product sterility and process improvements. The position requires an investigative approach by applying strong MQSA principles to deliver effective solutions to achieve regulatory requirements over a broad range of national and international standards. Responsible for root cause identification as well as the implementation of improvements. Accountable for developing technical solutions to drive improvements in activities such as: Non-conformances and CAPAs. Accountable for leading the design and validation of reusable device cleaning and disinfection validations and sterilization process validations for new products. Responsible for the E2E MQSA functions supporting marketed sterile single-use & reusable medical device products.
Key Responsibilities:
- Collaborate with various project teams (R&D, Quality, Operations, and Regulatory Affairs) and provide subject matter expertise for product lifecycle management.
- Drive compliance to existing and emerging regulatory standards in the areas of device reprocessing, scope reprocessing, cleaning and disinfection of capital equipment, and terminal sterilization of devices.
- Support the selection and assessment of contract laboratories as it relates to the E2E sterility assurance for products.
- Provide technical support for procurement-related activities for all products or components externally manufactured.
- Provide direct support to the extended sterility assurance team in the IQ, OQ, and PQ of controlled manufacturing environments for Auris Health products.
- Provide primary microbiological SME input in maintaining sterility assurance level (SALs) for Auris Health products and maintain substantiated sterilization validations (PQ, MPQ and PPQ) working directly with the operations team (internal/external).
- Coordinate sterilization validation and requalification sample testing through packaging facilities & approved laboratories, trend data and preparing reports.
- Develop test protocols, carry out experiments (including design of equipment/fixtures as needed), analyze test results, and prepare technical reports.
- Serve as the primary technical liaison for external contract laboratories and external manufacturers.
- Responsible for technical investigation for any non-conformities to the process.
- Accountable for driving technical improvements in activities such as Non-conformances and CAPAs.
- Ensure all industrial microbiological requirements comply with current industry standards and regulatory requirements.
- Responsible for writing instructions for use specific to reusable medical devices and capital equipment processing and execution of validations to support.
- Network with the internal and external scientific, technical, and regulatory community to maintain state-of-the-art knowledge.
Qualifications
Required:
- B.S. in Life Science or Engineering with specific coursework in Microbiology. Advanced degree preferred.
- A minimum of 6 years of Medical Device experience in terminal sterilization, industrial microbiology, and a strong background in device processing.
- Knowledge and experience in national/international standards in quality management systems, Industrial Sterilization, Cleanroom, and Environmental monitoring, developed skills in device reprocessing (critical, semi-critical, and non-critical capital equipment) and microbiological methods.
- Demonstrated results in Quality Control, Compliance, and Regulatory.
- Successful collaboration and cross-functional team experience in a matrix organization.
- Strong digital literacy and knowledge of various programs such as Microsoft Office, and SAP.
- Ability to travel up to 20% in North America required.
Preferred:
- Direct knowledge of surgical endoscope device design considerations cleaning and disinfection process.
- Direct knowledge of reusable medical device design considerations relating to cleaning, disinfection, and sterilization processes.
- Strategic thinking & big picture orientation.
- Influence Management abilities.
- Ability to adapt to changing priorities.
- Project management skills.
- Strong written & verbal communication skills.
The anticipated base pay range for this position is $101,800 to $163,990.
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.
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.