Sr. Scientist- MQSA (Supplier/EM)

Job Description

You will be responsible for:

• Supporting end-to-end Microbiological Quality & Sterility Assurance (MQ&SA) activities related to suppliers and external manufacturing processes
• Contributing to change requests and projects impacting controlled environments, cleaning, and sterilization processes
• Supporting contamination control strategies, including environmental monitoring and investigation activities
• Providing technical guidance and training on microbiological quality and sterility assurance
• Acting as subject matter expert for investigations, CAPA, non-conformances, audit observations, and risk assessments
• Supporting due diligence activities (e.g., acquisitions, partnerships) by providing MQ&SA expertise and risk input
• Supporting development and updates of supplier quality agreements
• Coeordinating and participating in supplier audits, including preparation, on-site support, response review, and follow-up activities
• Partnering with cross-functional teams to support supplier qualification and lifecycle management
• Contributing to remediation activities following audits or regulatory findings
• Building strong relationships with external partners, including manufacturers, suppliers, sterilization providers, and testing laboratories

Qualifications / Requirements

• A minimum of a Bachelor’s Degree in Microbiology, Biological Sciences or Engineering is required
• Minimum 4 years of experience with microbiological and sterilization in the medical device and/or pharmaceutical industry is preferred
• Strong knowledge of microbiological control, contamination control, and sterilization processes
• Familiarity with applicable standards and regulations (e.g., ISO, EN, AAMI)
• Experience conducting or supporting investigations, test method development, and validation
• Knowledge of regulatory and quality requirements related to suppliers and external manufacturing
• Experience supporting audits, inspections, or compliance assessments
• Strong communication and collaboration skills, with the ability to work across functions and levels
• Ability to work independently while contributing effectively to team objectives
• Fluent in English (Spanish is a plus)
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity