Director, Quality Microbiology

Role Overview

• Provide technical talent training, mentoring, and development support for microbiology personnel and cross-functional teams.
• Serve as a representative for microbiology globally and collaborate across functions such as quality, operations, R&D, Global Supply, Finance, Sales, and Marketing to ensure company goals are met.
• Act as a global process owner for microbiology and oversee the implementation of Global procedures to support compliance of Integra LifeSciences manufacturing site Microbiology Quality programs.
• Create and sustain long-term strategies and advise a team of managers and scientists across the Quality Microbiology team.
• Provide leadership and direction to the Quality Microbiology team to ensure business, quality, and compliance objectives are met.
• Report results of site microbiology programs to leadership for projects and key performance indicators.
• Resource business projects such as manufacturing transfer, acquisitions, new product development, etc. with microbiology personnel.
• Participate as a microbiology SME in internal audits, and external audits such as FDA inspections, ISO certifications, surveillance audits and customer audits.
• Maintain a strong working knowledge of standards and regulations including FDA CFR, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 22442, CMDR, Medical Device Directive, and USP.

Requirements

• Bachelor’s, or preferably Master of Science degree, in Microbiology or similar discipline.
• Minimum 12 years’ experience in medical device or regulated industry with 5 years of leadership experience, with experience in microbiology.
• Experience working with the manufacturing of tissue-based products and surgical tools as a microbiologist or similar scientific discipline in the medical device industry.
• Experience leading teams in the development and implementation procedures used in operations across multiple businesses/manufacturing sites.
• Advanced communication skills (written and verbal) with the ability to curate information to a diverse audience of stakeholders.
• Robust cross-functional collaboration skillset with the capability of driving quality and operational excellence.
• Advanced team leadership experience including mentoring, meeting facilitation, coaching, influencing, and negotiation.
• Capable of working autonomously and with independence when needed while maintaining strong performance.
• Demonstrated capability to develop strategic direction, goals, and guiding execution in a team-based working environment.
• Advanced experience working within Quality Systems including, but not limited to, change control, CAPAs, deviations, nonconformances, risk assessments.
• Direct experience representing a department in regulatory inspections and communications.
• Advanced technical writing skillset with the capability to interpret and author complex documentation.
• Working knowledge of applicable microbiology standards including, but not limited to, FDA CFR, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 22442, CMDR, Medical Device Directive, and USP.
• Ability to travel up to 25%.

Benefits

• medical
• dental
• vision
• life insurance
• short
• and long-term disability
• business accident insurance
• group legal insurance
• savings plan (401(k))