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
Coordinating 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

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

Vacation –120 hours per calendar year
Sick time
40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time
up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

Senior Scientist – MQSA, Supplier/EM

Key skills