Senior Microbiologist, Laboratory

Senior Microbiologist

Leesburg, VA or Allendale, NJ (10% Travel Required)

We're the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient outcomes in spine care. As a Senior Microbiologist in our CQR function within the Spine division, you'll lead Biological Safety activities - including Microbiology, Biocompatibility, Sterilization, and Cleaning - ensuring the safety and compliance of medical devices throughout their lifecycle.

Ensure and maximize biocompatibility of products, components, materials, and consumables using industry guidelines and advanced testing technologies

Perform microbiology, sterilization, biocompatibility, and chemical assessments for new product introductions, design/process changes, and day-to-day activities

Manage laboratory testing related to reprocessing, manufacturing (cleaning and sterilization), and biocompatibility according to procedures and standards

Oversee cleanroom environmental control (air, surface, particle viability) and facilities (e.g., water systems) in accordance with applicable standards

Interpret sampling and monitoring data using statistical and analytical techniques to determine control and trends

Own, drive, and support NC/CAPA activities, including non-conformance correction and root cause analysis

Manage relationships with cleaning service providers, sterilization and testing laboratories, and collaborate with the Supplier Quality team

Complete gap assessments of external documents related to biocompatibility, reprocessing, and manufacturing activities

Work cross-functionally with Manufacturing Engineering, R&D, Operations, and Regulatory Affairs to develop best practices

Participate in change control board activities and internal/external regulatory audits (FDA, BSI, GMED, etc.)

Execute quality initiatives that support compliance and continuous improvement of Biological Safety processes

Act as a subject matter expert in microbiology-related regulations and local procedures

Serve as backup for Biological Safety activities across sites as needed

Bachelor's degree in Microbiology or a related discipline (Biomedical Engineering, Biology, etc.)

• Minimum of 3 years of experience in a quality or regulatory affairs related environment
• Minimum of 2 years of experience as a Microbiologist focused on Cleaning, Biocompatibility, and Sterilization, plus 2 years related to microbiology and chemistry
• 2+ years of applied device or pharmaceutical microbiological or biological testing, R&D, or sterility assurance experience
• Understanding of sterilization techniques such as gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, dry heat, or other modalities
• Mandatory experience interacting with regulatory agencies (FDA, Department of Health, TUV, BSI, etc.)
• S. and international medical device regulations and standards in Biological Safety
• Highly proficient in statistical techniques, data review, and analysis
• Strong communication, negotiation, project management, and influencing skills
• Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay range for this position is $80,000.00 - $90,000.00 annually, with potential for bonuses and incentives plus benefits. Comprehensive health, dental, and vision insurance
• Paid time off (PTO) and holidays
• Ongoing training and professional development opportunities