Sr. Microbiologist

VB Spine, LLC•Leesburg, VA

4d•$80,000 - $90,000

About The Position

VB Spine is seeking a Sr. Microbiologist to join their high-performing CQR team. In this role, you will apply advanced knowledge of microbiological concepts, practices, and procedures related to various FDA, EU, and ISO standards to ensure and maximize the biocompatibility of products. You will perform and manage microbiology, sterilization, biocompatibility, and chemical assessments, oversee cleanroom environmental control, and interpret sampling data. This position involves supporting new product introductions, design changes, and day-to-day activities, managing laboratory testing, and acting as a subject matter expert in microbiology-related regulations. You will also participate in change control, audits, and quality initiatives, and coach/mentor team members.

Requirements

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

Responsibilities

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