Overview In this role you lead the global Quality Microbiology team across Tissue Technologies and Codman Surgical Specialties, steering microbiology programs to ensure compliant, high-quality manufacturing. You will partner with quality, operations, R&D, and other functions to drive performance, training, and strategic microbiology initiatives. You shape global procedures, oversee audits and regulatory readiness, and align team efforts with company quality objectives. This position blends leadership with hands-on microbiology expertise to advance patient outcomes and product standards.
Compensation / Benefits- medical, dental, vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- 401(k) savings plan
Responsibilities- Provide training, mentoring, and development support for microbiology personnel and cross-functional teams
- Represent microbiology globally, collaborating with quality, operations, R&D, Global Supply, Finance, Sales, and Marketing
- Act as global process owner for microbiology and implement Global procedures for site microbiology quality programs
- Create and guide long-term strategies for the Quality Microbiology team
- Lead the microbiology team to meet business, quality, and compliance objectives
- Report site microbiology program results and KPIs to leadership
- Resource projects such as manufacturing transfers, acquisitions, and new product development
- Participate as a microbiology SME in internal and external audits (FDA, ISO, surveillance)
- Maintain knowledge of standards and regulations (FDA CFR, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 22442, CMDR, MDD, USP)
Key requirements- Bachelor's in Microbiology (Master's preferred)
- Minimum 12 years in a medical device or regulated industry with 5+ years of leadership in microbiology
- Advanced written and verbal communication
- Cross-functional collaboration
- Strong leadership and mentoring ability
- Quality Systems experience (change control, CAPAs, deviations, nonconformances, risk assessments)
- Regulatory inspections and communications with regulators
- Technical writing and complex documentation
