What You Can Expect

The Microbiologist will be responsible for providing leadership, direction and execution of quality control tasks related to medical device product development and commercial products. The Microbiologist operates in a quality environment which is highly regulated and assures that Embody products are consistent and of high quality by managing, maintaining, and assisting in the operation and development of the QC laboratory functions, planning, continuous improvement, and execution.

The Microbiologist is responsible for the oversight, coordination, and execution of routine and non-routine sampling, microbiological, biochemical, and mechanical testing for release of product, in-process and raw materials, product release, and the environmental monitoring (EM) program of the production facility, test method and equipment validation. Additional responsibilities outside the laboratory include out of specification investigations and complex data analysis and review.

The Microbiologist reports directly to the Embody Quality Manager.

How You'll Create Impact

• Responsible for the oversight of the QC laboratory, ensuring compliance with all quality and regulatory standard requirements (Good Manufacturing Practices (GMP), ISO 13485, 21 CFR 820).
• Responsible for the oversight of the environmental monitoring (EM) program (cleanrooms and controlled production spaces), including but not limited to viable and non-viable air monitoring, surface microbial monitoring, characterization of microbial strains, data analysis of environmental monitoring data. Responsible for cleanroom and controlled production space EM validations.
• Ensure completion of all analytical and bio-analytical testing including product development project/protocol testing.
• Responsible for oversight and execution of incoming inspection, in-process, and finished good QC testing and product release including but not limited to visual and dimensional inspection, mechanical and biomechanical testing, biological (e.g., endotoxin) testing, and documentation of all test results including deviations.
• Ensure product testing plan attainment, and that all products released meet the pre-determined quality control requirements. Manages sample coordination prior to and following testing activities. Manage quality control planning in collaboration with production.
• Develop, document, and implement QC procedures, train QC personnel, and define, procure, manage, and maintain QC analytical lab equipment.
• Responsible for the development and execution of method suitability and equipment validation/qualifications (IQ, OQ, PQ).
• Monitor the testing techniques and accuracy of all records and documentation, ensuring that all documentation is prepared, reviewed, and revised as per regulatory requirements.
• Analyze data, generate trend/summary reports, and distribute periodic quality performance reports. Responsible for conducting complex data analysis and review generated from routine and non-routine testing.
• Review and approve environmental monitoring data and laboratory equipment and records.
• Lead and support quality issues by problem solving, root cause analysis, and identifying potential solutions.
• Authorized to release and transfer in-process and finished material in ERP system for sale, distribution, or further use.
• Performs laboratory maintenance activities including but not limited to equipment preventative maintenance, calibration, disposal of waste, and cleaning QC laboratory areas.
• Initiate pro-active initiatives to impact production, increase efficiency, and cost-savings in the laboratory.
• Work with operations and product development to support continuous quality improvement initiatives.
• Adhere to all general and laboratory safety policies, manufacturing procedures, company policies, and FDA 21 CFR 820, GMP, and ISO 13485 regulatory requirements.

What Makes You Stand Out

• Bachelor’s degree in Microbiology, Biology, or similar discipline
• Minimum 5+ years of medical device industry experience
• Knowledge and practical application of FDA Quality System Regulations and guidelines (21CFR820), ISO 13485, and Good Manufacturing Practice (cGMP)
• Experience with common laboratory skills and analytical methodologies (spectroscopy, bioburden, endotoxin, etc.), laboratory equipment, microbiology culturing techniques, and working in clean rooms.
• Detailed knowledge and experience in applying statistical concepts to laboratory data.
• Demonstrated competency in advanced quality testing technologies. Knowledge about a variety of microbiological concepts, practices, and procedures.
• Preferred knowledge and practice in ethylene oxide and electron beam sterilization techniques preferred.
• Ability to effectively work cross-functionally with Product Development, Operations, Quality Assurance and Regulatory. Demonstrated communication skills across different organizational levels.

Travel Expectations

• <10%