About this opportunity
VB Spine lists this Sr. Microbiologist opportunity in leesburg, Virginia. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Senior Microbiologist
Location: Leesburg, VA or Allendale, NJ (10% Travel Required)
Company: VB Spine
Looking for a career where your work truly matters? At VB Spine, you'll be part of a mission-focused team that supports surgeons during life-changing spinal procedures. 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.
What You'll Do:
Apply advanced knowledge of microbiological concepts, practices, and procedures related to FDA, EU, ISO 17664, ISO 17665, ISO 10993, AAMI ST79, AAMI TIR 30, AAMI TIR 12, and applicable BS EN ISO standards
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
Actively support and advise on existing processes and new product development
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
Continuously identify opportunities for trend stabilization and statistical process control to drive cost savings
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
Perform validations/(re)qualifications and develop/improve SOPs and work instructions aligned with evolving standards
Act as a subject matter expert in microbiology-related regulations and local procedures
Coach, mentor, and train team members and functional groups in Biological Safety
Serve as backup for Biological Safety activities across sites as needed
What You Bring:
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.)
Excellent knowledge of U.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
Critical thinking, innovative reasoning, and excellent problem-solving abilities
Ability to work independently, manage multiple priorities, and mentor others
Why VB Spine? We believe in growing talent from within. At VB Spine, join a high-performing CQR team where your expertise in Biological Safety will directly ensure the safety and compliance of innovative spinal products that improve patient lives.
Compensation: 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. Final compensation is determined on a case-by-case basis and considers a variety of factors including experience level, technical expertise, and market conditions.
Benefits include:
Comprehensive health, dental, and vision insurance
401(k) with company match
Paid time off (PTO) and holidays
Ongoing training and professional development opportunities
Opportunity to grow within a fast-paced, dynamic company
Worksite address
leesburg, VA, 22075, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.