Senior Microbiologist: Biocompatibility & Sterilization Lead

VB Spine, LLC; Leesburg, Northern (VA, KY); Hybrid; USD 80,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401(k) matching

Paid time off

Job summary

VB Spine is seeking a Senior Microbiologist to lead Biological Safety activities across microbiology, biocompatibility, sterilization and cleaning for medical devices. The role involves overseeing lab testing, facilitating reprocessing and biocompatibility assessments, and guiding CAPA and change controls with cross-functional teams.

You have a strong background in regulatory affairs, experience with FDA/ISO standards, and the ability to mentor others while improving processes.

Qualifications

• Experience with FDA/EU/ISO/BSI standards and regulatory guidelines.
• Strong statistical and data interpretation skills.
• Ability to manage multiple priorities and mentor others.

Responsibilities

• Lead Biological Safety activities across microbiology, biocompatibility, sterilization, and cleaning.
• Oversee lab testing related to reprocessing and biocompatibility.
• Coordinate with QA, Regulatory, and Manufacturing teams on audits and CAPAs.
• Drive continuous improvement and SOP development in Biological Safety.

Skills

Statistical analysis

Regulatory affairs experience

Communication

Project management

Mentoring

Independent work

Education

Bachelor’s degree in Microbiology

Job description

VB Spine is seeking a Senior Microbiologist to lead Biological Safety activities across microbiology, biocompatibility, sterilization and cleaning for medical devices. The role involves overseeing lab testing, facilitating reprocessing and biocompatibility assessments, and guiding CAPA and change controls with cross-functional teams.

You have a strong background in regulatory affairs, experience with FDA/ISO standards, and the ability to mentor others while improving processes.