Director, Quality Microbiology

Director, Quality Microbiology position leading operational microbiology teams across tissue technologies and surgical specialties businesses. Reports to Corporate Quality Sterility Assurance with responsibilities for team development, global process oversight, regulatory compliance, and cross-functional collaboration across manufacturing sites.

Responsibilities

• Lead and mentor microbiology personnel and cross-functional teams in technical training and development
• Serve as global microbiology process owner and oversee implementation of procedures across manufacturing sites
• Represent microbiology in internal and external audits including FDA inspections and ISO certifications
• Create long-term strategies and provide leadership direction to ensure quality, compliance, and business objectives
• Report site microbiology program results and key performance indicators to leadership

Requirements

• Bachelor's degree in Microbiology or related discipline; Master's preferred
• Minimum 12 years medical device or regulated industry experience with 5 years leadership in microbiology
• Subject matter expertise in controlled environment qualification, water systems, and bioburden testing
• Advanced team leadership with mentoring, facilitation, and cross-functional collaboration capabilities
• Working knowledge of FDA CFR, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 22442, and USP standards
• Experience with quality systems including change control, CAPAs, deviations, and risk assessments
• Ability to travel up to 25%

Compensation: $166,750.00 - $228,850.00 USD base salary